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- 2026-05-03 14:48:41
- Policy
- 1st bispecific antibody Epkinly approved with a condition
- by Lee, Hye-Kyung Jul 09, 2024 05:51am
- 'Epkinly (epcoritamab),' the first T-cell–engaging bispecific antibody, was found to have been approved under the condition that the company submits Phase III trial data. In Korea, the approval was granted on March 20 based on Phase II clinical trial data and a Phase III trial protocol, but at the time, a condition was added that the company must submit data from a therapeutic confirmatory trial. According to the minutes of the Central Pharmaceutical Affairs Committee meeting held in April, which were recently released by the Ministry of Food and Drug Safety, Epkinly was granted conditional approval and was required to submit Phase III trial results after the approval of the product by applying Article 24, Paragraph 3 of the 'Regulations for Approval and Review of Biological Products, etc. 'Epkinly (epcoritamab),’ which is imported by Abbvie Korea, is a bispecific monoclonal antibody that binds to both the CD3 on the surface of T-cells and CD20 on the surface of B-cells and is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of systemic therapy In Korea, Polivy, Kymriah, Selinexor, and Columvi are approved for the treatment of patients with relapsed or refractory DLBCL. DLBCL is one of the most common blood cancers and is one of the most common types of widely spread (diffuse) non-Hodgkin lymphoma, characterized by rapid progression. Epkinly binds to CD3 to activate T cells and binds to CD20 to bring B cells to the side of activated T cells and induce B cell death. In this regard, a CPAC member said, "In a clinical trial in patients with persistent relapses requiring 3 or more cycles of treatment, Epkinly demonstrated some degree of effectiveness and safety. Its effectiveness and safety have been confirmed over other existing drugs, so we deemed granting conditional marketing authorization was appropriate pending the results of its Phase III clinical trial." When the U.S. FDA granted the drug through its accelerated approval program, the approval was based on the Phase I/II EPCORE NHL-1 study. In 148 patients with relapsed or refractory DLBCL who had received a median of 3 prior therapies, the drug demonstrated an objective response rate of 61%, a complete response rate of 38%, and a median duration of response of 15.6 months in patients with CD20-positive diffuse large B-cell lymphoma. Another CPAC member added, "Based on the Phase II results, Epkinly appears to be an effective and safe agent when compared to other 2nd or later line agents. Therefore, we believed the conditional approval was warranted, subject to submission of its Phase III results."
- Company
- Takeda seeks top-line growth to KRW 300 billion
- by Hwang, Byung-woo Jul 09, 2024 05:51am
- Takeda Pharmaceuticals Korea achieved a double win last year, seeing improvements in sales and operating income. In particular, thanks to the growth of its anti-cancer drug portfolio, the company's sales exceeded the KRW 250 billion mark for the first time in 3 years since 2020, increasing sales growth for the second consecutive year. Takeda Pharmaceuticals Korea logoIn the long run, the key question will be whether the growth of products such as Obizur, which will be listed for reimbursement this year, can offset the decline in sales of Dexilant and Pantoloc. Japanese pharmaceutical companies count the period from April 1 to March 31 as the first fiscal year, and the 16th fiscal year audited report, which includes last year's sales, records performance from April 1, 2023, to March 31, 2024. Sales rebound since 2021... second consecutive year of growth According to the audit reports disclosed in the Data Analysis, Retrieval and Transfer System (DART), Takeda Pharmaceuticals Korea’s (Takeda Korea) 16th fiscal period sales amounted to KRW 253.9 billion, surpassing the KRW 250 billion mark for the first time in 3 years. Takeda had posted sales of KRW 252.6 billion in 2020, and the sales fell to KRW 231.5 billion in 2021. It then rebounded to KRW 249.5 billion in 2022 and continued its upward trend. In line with the revenue growth, operating profit also rose, reaching KRW 9 billion. This is the highest in the last 5 years, with operating profit in the last 4 years being KRW 8.1 billion in 2020, KRW 8 billion in 2021, and KRW 7.5 billion in 2022. Net income also grew from KRW 6.8 billion to KRW 7.9 billion during the same period. This revenue growth indicates that Takeda Korea improved externally and internally last year. This was influenced by the company’s decrease in selling, general, and administrative expenses (SG&A). Commissions paid decreased from KRW 19.5 billion in the 15th period to KRW 5.1 billion in the 16th period, offsetting the increase in other SG&A expenses. In the footnote, it was indicated that the amount of commission paid to Baxalta GmbH of KRW 25.8 billion in the 15th period was eliminated in the 16th period with the company being merged and acquired by Takeda Pharmaceutical International AG. (from the left)Adcetris, ZejulaOncology products lead sales growth...sees sales growth in all major items Takeda Korea's sales recovery to KRW 250 billion was driven by growth in its oncology portfolio. Sales of Alunbrig and Adcetris grew more than 20% year-on-year, and Zejula grew 19%. According to the drug research institution IQVIA, Luprin recorded the highest sales of KRW 30.6 billion. After reaching KRW 32.2 billion in 2019, sales dropped to KRW 27.6 billion in 2022 but surpassed the KRW 30 billion mark again in 2023. In addition, Zejula, which is expanding its influence every year, had the second highest sales among anti-cancer drugs, with sales of KRW 22.6 billion in 2023, up from KRW 19 billion in 2022, and Alunbrig's sales increased from KRW 11 billion to 13.6 billion won during the same period. Sales of Adcetris showed the highest growth. Its sales increased by 29%, from KRW 7.6 billion in 2022 to KRW 9.8 billion in 2023. Taken together, the sales growth of major anticancer drugs last year was about KRW 13 billion. As a result, the company’s oncology portfolio will continue to drive sales growth this year. However, there is the possibility that Adcetris' sales growth may be limited hereon due to its lowered drug price cap on July 1. GI drug sales will inevitably decline...Obizur’s reimbursement is soon expected In the GI space, Mezavant's sales growth was notable. It crossed the KRW 10 billion mark for the first time with sales of KRW 10.1 billion in 2023, up 26% from the KRW 8 billion in 2022. In addition, sales of Kinteles grew 14% to KRW 16.5 billion in 2023 (from KRW 14.5 billion in 2022), and orphan drug Replagal grew 17% to KRW 16 billion (from KRW 13.6 billion in 2022). However, there were also some items that took a turn for the worse. Sales of Dexilant and Pantoloc decreased 8% (from KRW 16.7 billion to KRW 15.3 billion) and 7% (KRW 13.3 billion to KRW 12.4 billion), respectively, compared to 2022, and sales of Adynovate decreased by nearly 20%, from KRW 6.8 billion in 2022 to KRW 5.4 billion in 2023. Considering this, there are voices that it is necessary to prepare a portfolio to expand sales in the long term. The most anticipated item is the reimbursement of Obizur, a treatment for adults with acquired hemophilia A, which was reimbursed in February. The drug for the rare blood disorder has a limited patient population but is expected to contribute to sales with its differentiated sales.
- Policy
- BMS’ Camzyos and Handok’s Empaveli pass the DREC review
- by Lee, Tak-Sun Jul 09, 2024 05:51am
- Bristol Myers Squibb Korea’s 'Camzyos Cap,' a treatment for symptomatic obstructive hypertrophic cardiomyopathy (oHCM), has passed the Drug Reimbursement Evaluation Committee (DREC) review after reconsideration. Handok’s 'Empaveli Inj,' a treatment for paroxysmal nocturnal hemoglobinuria (PNH), also obtained approval for reimbursement and moved on to negotiations. The Health Insurance Review and Assessment Service (HIRA) commenced the 7th Drug Reimbursement Evaluation Committee (DREC) of 2024 and announced that it had decided the appropriateness of reimbursement for these drugs. The review outcome of assessing the appropriateness of benefit coverage for drugs that have applied for a decision: Three pharmaceuticals have been considered for this round of DREC review. The symptomatic oHCM treatment, Camzyos Cap, a PNH treatment, Empaveli Inj, and an NMOSD treatment, Uplizna Inj, received the assessment. Among these, Camzyos Cap and Empaveli Inj obtained appropriateness of reimbursement decisions. Two drugs are expected to undergo drug pricing negotiations with the HIRA and will receive the final decision for reimbursement listings. Camzyos received the reconsideration decision from the DREC review held last month. In just one month, DREC granted the reimbursement appropriateness. On the other hand, Uplizna Inj received a decision that it will meet the appropriateness of reimbursement if the company accepts an amount below the standard. If Mitsubishi Tanabe Pharma accepts an amount below the standard, the drug will be considered for negotiations with the HIRA. If the company fails to take it, the drug will not be listed for reimbursement. If the company accepts an amount below the standard for exemption from the drug pricing negotiations, it will only negotiate the expected claim amount.
- Policy
- Reassessing the comparison of foreign drug pricing is 'idle'
- by Lee, Tak-Sun Jul 08, 2024 05:46am
- The 10th public-private meeting has been held to reassess the comparative methods of foreign drug pricing. However, they exchanged different opinions without reaching a concrete decision. Pharmaceutical industry has particularly opposed to the use of drug pricing references from Germany and Canada. It remains to be seen how the two parties will continue the discussion regarding this matter. According to industry sources, the 10th meeting to reassess the comparative methods of referencing foreign drug pricing was held on the morning of July 5th. The government initially planned to convene the meeting in June, planning to complete gathering opinions, but due to schedule delays, the meeting took place in July. This indicates that the government has considered the current meeting as the final round of gathering opinions. However, the pharmaceutical industry, the attendee of the meeting, argues that further discussion is needed. The differences in opinions are in the reference drug pricing in Germany and Canada, which the government compares drug prices to. The Korean government advocates public reimbursement prices as the reference, while the pharmaceutical industry argues for sales prices. They argued strongly about this matter during the current meeting. The industry argues that comparing Korean drug prices by referencing the public reimbursement price in Germany and Canada, which are also implementing reference-pricing systems, will distort the differences in drug pricing. Under those countries’ reference-pricing systems, China and India’s low-priced generics are frequently reimbursed. The industry argues that the government’s current comparison method works against its aim to set a reasonable drug price by making comparisons to advanced countries (A8). The meeting confirmed the differences in opinions of the government and the industry. Therefore, it remains to be seen whether there will be a next meeting. Since the government claims to have gathered enough feedback, it will likely maintain its current position. Drug pricing is anticipated to be set this year by implementing a weighted mean price comparison method, excluding the highest and lowest drug prices of A8 countries, every three years. It will be applied to pharmaceuticals for chronic diseases that expect patent expirations. The government is likely to pursue the current drug pricing reference sources. However, the two parties are likely to communicate privately until the government makes an official announcement. As a result, the final proposal may change.
- Company
- HCV testing added to the National Health Screening Program
- by Hwang, Byung-woo Jul 08, 2024 05:46am
- The government's decision to introduce the long-discussed hepatitis C antibody testing to the national screening program is expected to have a positive impact on its treatment market. According to industry sources, the decision is encouraging as it enables the first step of identifying hepatitis C patients. However, how to link diagnosis and treatment will be a challenge in the future, as the treatment rate has been dropping despite patient identification. Recently, the Ministry of Health and Welfare held the 2nd National Health Screening Committee Meeting in 2024 and confirmed the introduction of new hepatitis C testing and the expansion of osteoporosis screening subjects in Korea’s general health screening program. As a result of the decision, people aged 56 and older will be able to receive an antibody test for hepatitis C during national health screening from 2025. According to the Korean Association for the Study of the Liver (KASL), hepatitis C is responsible for about 10% to 15% of liver cancer cases in Korea. Between 54% and 86% of hepatitis C patients progress to chronic hepatitis, and 15% to 51% of which progress to cirrhosis. The risk of liver cancer in cirrhosis is 1-5% per year, with the risk increasing with age. However, hepatitis C can be cured by taking oral antiviral drugs for 8 to 16 weeks, so screening and treating infected people early is the best way to prevent the spread of the disease. This is why the pharmaceutical industry’s hopes are rising on how the introduction of hepatitis C testing will lead to increased patient identification and treatment. An industry official said, "There had been a large unmet need in hepatitis C, but due to a lack of policy and awareness, many patients were unaware of their infection and were diagnosed late, often after the disease had progressed to liver cancer. The industry is pleased that a meaningful policy has been established." Will sales of AbbVie and Gilead’s treatments also rebound? Currently, the leading hepatitis C treatments are AbbVie’s Mavyret (glecaprevir/pibrentasvir) and Gilead Sciences' Epclusa (sofosbuvir/velpatasvir) and Vosevi (velpatasvir/sofosbuvir/voxilaprevir). In terms of sales, Mavyret sold KRW 57.3 billion in 2019, KRW 46.9 billion in 2020, KRW 46.6 billion in 2021, KRW 39.3 billion in 2022, and KRW 24.3 billion in 2023, showing a yearly decline. Epclusa and Bosebi Vosevi to generate sales in earnest after being granted reimbursement in November 2022, generating KRW 16.1 billion and KRW 3.5 billion respectively last year. In general, Mavyret’s sales have declined with Epclusa and Bosebi taking its place. However, the overall market for hepatitis C drugs has been on a decline or drifting sideways. Since 2020, the combined sales of the 3 products have been in the low to mid KRW 40 billion range. This is not unrelated to the decline in the number of hepatitis C patients in Korea. According to statistics from the Korea Disease Control and Prevention Agency’s Infectious Disease Portal, the number of hepatitis C patients decreased from ▲11,849 in 2020 to ▲11,115 in 2021, ▲8,308 in 2022, and ▲7,225 in 2023 Considering this situation, the introduction of hepatitis C antibody testing in the national health screening program is expected to lead to an increase in the use of hepatitis C treatment as well. An official from the KASL said, "Our society has been pondering how to combat hepatitis C for a long time, and although it is late, we are glad that screening for hepatitis C became possible through the national health screening program. The increase in screening will help us identify and treat patients at an earlier stage." However, there is also a view that additional efforts would need to be made to actively treat patients even after the national screening. According to KASL’s Fact Sheet which was published in 2023, the cure rate for hepatitis C patients was only 58.1% in 2019. This means that 4 out of 10 people diagnosed with hepatitis C do not actually receive treatment. It's also unclear how well the national screening program will be able to identify patients, given that the target age for screening is 56. For this reason, the KDCA is working on a plan to subsidize the cost of confirmatory tests for those who test positive for hepatitis C antibodies in the national health screening program so that they can be confirmed faster. A doctor at A General Hospital said, "The problem in Korea has been the low screening rate itself. Various studies have been conducted on how to treat the confirmed patients afterward. I think the introduction of hepatitis C testing in the national health program will increase patient treatment as well as the use of treatment."
- Company
- New PNH drugs introduced into AstraZeneca’s reign
- by Son, Hyung-Min Jul 08, 2024 05:45am
- Competition is in full swing in the paroxysmal nocturnal hemoglobinuria (PNH) market, which is currently dominated by AstraZeneca's treatments such as Soliris and Ultomiris, with the introduction of new drugs that have new mechanisms of action soon to emerge in the market. Recently, Handok's Empaveli is nearing reimbursement in Korea, and Novartis has filed for domestic marketing authorization of its new drug Fabhalta. Amid the introduction of such new drugs, AstraZeneca is defending its market by receiving approval for Voydeya, which is used as an adjuvant therapy with Soliris and Ultomiris. According to industry sources on the 6th, Handok's Empaveli (pegcetacoplan) was approved adequate for reimbursement by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee. Empaveli passed the committee 2 months after being approved in May, ahead of drug pricing negotiations with the National Health Insurance Service. New PNH drug introduced by Handok in Korea Empaveli is a treatment for paroxysmal nocturnal hemoglobinuria (PNH) developed by the U.S. company Apellis. The drug’s license in countries other than the U.S. is owned by the Swedish Orphan Biovitrum (Sobi). Handok entered into a strategic partnership with Sobi in October last year to introduce Empaveli in Korea. PNH is a rare and life-threatening disease caused by the destruction of red blood cells in the blood vessels, leading to symptoms of bloody urine and complications such as acute renal failure. Empaveli is the first PNH treatment to target the C3 protein. By blocking C3 cleavage, the drug prevents intravascular and extravascular hemolysis. Empaveli’s efficacy was confirmed over Soliris (eculizumab) in the Phase III PEGASUS trial. In the study, the level of lactate dehydrogenase (LDH), a marker of intravascular hemolysis, remained below 1.5 times the upper limit of normal for 48 weeks in the Empaveli treatment arm. The percentage of patients who remained transfusion-free for 16 weeks was also higher in the Empaveli treatment arm (85%) compared with the Soliris arm (15%). The efficacy of Empaveli was also confirmed in the PRINCE trial in treatment-naïve PNH patients. After 26 weeks of follow-up, 85.7% of patients in the Empaveli arm showed stable hemoglobin levels, and LDH levels were well controlled to normal levels in the Empaveli arm. In addition to Empaveli, other new drugs from multinational pharmaceutical companies are also preparing to enter Korea. Novartis recently submitted a new drug application (NDA) for its PNH drug Fabhalta (iptacopan) in Korea. Novartis Fabhalta is a factor B inhibitor that acts proximally in the immune system's alternative complement pathway, providing comprehensive control of red blood cell destruction. The advantage of Fabhalta is its formulation. As an oral agent, Fabhalta offers dosing convenience compared to the existing intravenous formulations like Soliris and Ultomiris (ravulizumab). Fabhalta’s efficacy was confirmed in patients who failed complement C5 inhibitor treatment or had received no prior therapy. Study results showed that 82% of patients in the Fabhalta arm achieved a 2g/dL increase in hemoglobin at week 24 without red blood cell transfusions. In addition, Roche's C5 complement inhibitor Piasky (crovalimab) also showed clinical benefit. Piasky demonstrated non-inferiority to Soliris across multiple endpoints, including the rate of abrupt hemolysis and the rate of hemoglobin level stabilization. AZ Voydeya approved in Korea as add-on therapy to Soliris and Ultomiris The PNH market has been dominated by AstraZeneca, which owns new C5 complement inhibitor class drugs, including Soliris and Ultomiris. However, the introduction of other new drugs is expected to increase competition in the area. AstraZeneca will defend the market with its oral factor D inhibitor, Voydeya add-on therapy. Voydeya was approved in Korea on March 28 as an add-on therapy for PNH patients with symptoms or signs of extravascular hemolysis (EVH) who are using Soliris and Ultomiris. Complement C5 inhibitors are expected to complement the development of EVH and anemia experienced by some patients with PNH. Voydeya has received the Breakthrough Therapy designation in the U.S. and PRIority MEdicines (PRIME) status in Europe. Voydeya's domestic approval was based on the Phase III ALPHA trial. In the trial, Voydeya met its primary endpoint of change in hemoglobin level in patients on C5 complement inhibitors that experience EVH. Specifically, Voydeya demonstrated an improvement compared with placebo in the primary endpoint of change in hemoglobin concentration from baseline to week 12. Voydeya also achieved a 60% increase in hemoglobin of 2g/dL or greater at Week 12 without transfusion compared to 0% with placebo. In terms of safety, the most common treatment-emergent adverse events were headache and diarrhea.
- Company
- K-Bio receives FDA Orphan Drug Designations with novel drugs
- by Son, Hyung-Min Jul 08, 2024 05:45am
- In the first half of the year, Korean biopharmaceutical companies succeeded in obtaining numerous Orphan Drug Designations. Few patients have rare diseases but developing innovative new drugs can create added value and an exclusive position in the market. In the United States, if a drug is designated as an orphan drug, it is provided seven years of the market exclusivity period. Additionally, the company is provided with support for development and reduced taxes. After completing a phase 2 trial, the drug can be conditionally sold. As a result, biopharmaceutical companies in Korea actively seek FDA orphan drug designation. According to industry sources on July 8th, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to novel drug candidates from Boryung, Rzynomics, NeoImmunetech, SPARK Biopharma, SN BioScience, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm and GC Biopharma, and GI Innovation. FDA ODD program grants companies that have developed treatments for fewer than 100,000 patients with rare and incurable diseases incentives such as expedited review, reduced taxes, and market exclusivity. K-Bio pharmaceuticals with FDA-approved Orphan Drug Designations in the first half of the year. (From the top, by month) Novel drug candidates from Boryung (BR-101801), Rzynomics (RZ-001), NeoImmunetech (NT-I7), SPARK Biopharma (SBP-401), SN BioScience (SNB-101), Oscotec (cevidoplenib), Ingenium Therapeutics (Gengleucel), Dr. Noah Biotech (NDC-011), Hanmi Pharm and GC Biopharma (LA-GLA), and GI Innovation (GI-102). Boryung’s BR-101801, a novel drug candidate to treat blood cancer, was the first to receive FDA ODD this year. Boryung is investigating the potential of BR-101801 in various blood cancers, including peripheral T-cell lymphoma and mycosis fungoides. In January, it received the approval for the treatment of angioimmunoblastic T-cell lymphoma. BR101801 is the first-in-class drug candidate to inhibit phosphoinositide 3-kinase (PI3K)γ/ δ and DNA-dependent protein kinase (DNA-PK). It can effectively induce cell death through triple target inhibition and suppress a cancer protein c-Myc. In recently disclosed phase 1b study results, BR101801 was demonstrated as a potential candidate to treat various lymphomas. The clinical studies evaluated the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma (11 patients), T-cell lymphoma (11 patients), diffuse large B-cell lymphoma (2 patients), and marginal zone lymphoma (1 patient). Over a follow-up of 12.9 months (median value), the objective response rate (ORR) in 19 evaluable patients with peripheral T-cell lymphoma and T-cell lymphoma was 31.6%. 4 patients showed complete response (CR), and 2 showed partial response (PR). The progression-free survival (PFS) was confirmed to be 7.5 months, but overall survival (OS) and duration of response (DOR) did not reach median values. For the safety profile, the most common adverse reactions occurred were rashes, an increase in AST/ALT, and coughs. Treatment-associated death did not occur. Boryung plans to apply for a Phase 2 Investigational New Drug (IND) application next year and continue to investigate the efficacy of BR101801. NeoImmuneTech’s NT-I7 received an ODD in the treatment of pancreatic cancer. NT-I7 is a novel drug candidate that targets interleukin (IL)-7, which regulates T-cell development and function. It has been investigated for various indications. Besides the current ODD for pancreatic cancer, NT-I7 received ODDs in the treatment of CD4 lymphocytopenia (2019), multifocal leukoencephalopathy (2020), and glioblastoma (2023). The current ODD in the treatment of pancreatic cancer was based on the Phase 2a results investigating Keytruda combination therapy. The study evaluated the effectiveness and safety of NT-I7 in combination with Keytruda in 50 patients with metastatic colorectal cancer and 48 pancreatic patients who had previously undergone treatments. The clinical results indicated that 3 out of 48 patients with pancreatic cancer have shown partial response (PR). The median overall survival time (OS) was 11.1 months. Additionally, NeoImmuneTech plans to investigate the potential of NT-I7 in combination with cancer vaccines. A Fabry disease treatment, ‘LA-GLA,’ which is under joint development by Hanmi Pharm and GC Biopharma, successfully received an ODD in the United States. LA-GLA is formulated for once-per-month subcutaneous administration. Fabry disease is a type of lysosomal storage disorder (LSD) resulting from a deficiency in a particular enzyme due to a genetic cause, leading to metabolic alterations. Last month, Hanmi Pharm disclosed results demonstrating that LA-GLA inhibits cell death in podocytes, which is important for kidney function in Fabry disease patients. Also, LA-GLA has significantly improved the peripheral sensory functions and histopathological features of nerve cells. Last month, GI Innovation’s GI-102, a candidate immunotherapy for cancer, received FDA ODD. The company is developing GI-102, which acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells. According to the clinical results disclosed at the American Society of Clinical Oncology (ASCO 2024) annual meeting, held in Chicago, U.S., response rates of GI-102 have been confirmed in various diseases, such as melanoma and non-small cell lung cancer (NSCLC). An ORR of 17.4% was observed in 23 patients (7 skin melanoma patients, 4 NSCLC patients, and 3 ovarian cancer patients). The reported overall ORR was 42.9%, and the disease control rate (DCR) was 85.7%, including three cases of partial response (cPR) confirmed in patients with metastatic skin melanoma who had previously experienced ICB. GI Innovation aims to obtain conditional approval for its GI-102 and is assessing the potential for technology transport. They are also examining the potential of using GI-102 in combination with NK cell therapy, as well as GI-102 monotherapy.
- Company
- Roche Korea starts reimb process for Columvi in Korea
- by Eo, Yun-Ho Jul 08, 2024 05:45am
- The reimbursement listing process for ‘Columvi,' the first bispecific antibody treatment option for lymphoma, will begin in Korea. According to Dailypharm coverage, Roche Korea's CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) is expected to be presented to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee meeting on the 10th. Columvi was approved in Korea last December for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. The drug is a third-line treatment option for DLBCL, like Novartis’s chimeric antigen receptor (CAR)-T-cell therapy Kymriah (tisagenlecleucel). The two drugs have different benefits; therefore the choice will likely be based on each patient's condition and circumstance. Columvi demonstrated efficacy in the Phase I/II NP30179 trial in 155 patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate(ORR) of 81%. The efficacy was also consistent across all subgroups. The most common adverse event was cytokine release syndrome (CRS). Adding to the encouraging data, at the 2024 Congress of the European Hematology Association (EHA 2024), the company unveiled the results of the Phase III STARGLO study, which demonstrated an improvement in overall survival (OS) with Columvi. The STARGLO study enrolled patients with relapsed or refractory (R/R) diffuse DLBCL who were not eligible to receive an autologous stem cell transplant after one or more prior systemic therapies, or who had received two or more prior systemic therapies. In the primary analysis (median follow-up 11.3 months), Columvi and gemcitabine+oxaliplatin (GemOx) combination significantly improved the primary endpoint of OS with a 41% lower risk of death compared to rituximab+GemOx. Seok Jin Kim, Professor of Hematology and Oncology at Samsung Medical Center, said, "There had been much unmet need in DLBCL for more effective third-line treatment options for patients who fail first-line or experience repeated relapses. We expect the introduction of Columvi to significantly improve the outcomes for patients with relapsed or refractory lymphoma in Korea."
- InterView
- “Prolia demonstrated a long-term treatment effect"
- by Son, Hyung-Min Jul 05, 2024 05:49am
- David Dempster (Hons), Professor at Columbia University in the United States“Prolia has consistently been proven to increase bone density based on clinical trials conducted over 10 years. Patients prescribed with Prolia have demonstrated such. Based on this evidence we hope that Prolia’s preventative effect on bone fracture becomes known in South Korea.“ During a recent meeting with Daily Pharm, David Dempster, (Hons) Professor at Columbia University in the U.S., assessed the osteoporosis treatment, Prolia (denosumab), as such. Osteoporosis is a chronic disease that weakens bones due to lowered bone density, and it cannot be completely recovered. After the diagnosis of osteoporosis, inadequate treatment may lead to a bone fracture with a minor fall in daily life. Once an osteoporotic fracture occurs, the risk of another bone fracture increases tenfold, and repeated incidents lead to a worsened prognosis. Preventing bone fracture through a long-term and consistent treatment is critical for osteoporosis. Since May, the Ministry of Health and Welfare (MOHW) expanded the National Health Insurance criteria for receiving major osteoporosis medications, including Prolia. Previously, patients could receive reimbursement at a T-score below -2.5, a bone mineral density test criteria. After the reimbursement revision, osteoporosis patients can receive reimbursement for osteoporosis medications for up to two years at a T score of over -2.5 or above or below -2.0 at the follow-up tests. Professor Dempster said that expanding the reimbursement criteria was the right decision, and emphasized the importance of preventing osteoporotic bone fractures through continuous medication treatment. Real World Data over 10 years demonstrated the effectiveness of Prolia Based on 10-year FREEDOM and FREEDOM Extension studies, Prolia showed a higher effect on reducing bone fractures compared to alendronate, a previous osteoporosis medication. In a real-world study conducted among 478,651 postmenopausal osteoporosis patients in the United States with no prior treatment history, Prolia reduced the risk of non-vertebral fractures, excluding hip fractures by 50% and major osteoporotic fractures by 39% compared to alendronate. After one year of treatment, Prolia demonstrated a greater reduction in bone fractures than alendronate. Studies indicate that the longer the treatment duration, more significant the decrease in the risk of bone fractures. “Prolia is a superior medication compared to conventional treatments in many aspects. This treatment provides effective results and offers high convenience with its once-every-six-month dosing schedule. Most elderly osteoporosis patients often already take medications for other conditions, making it burdensome to take additional oral medications. Additionally, some treatments have complex dosing regimens, causing various challenges in administration,“ Professor Dempster said. With previous treatments like alendronate, most patients typically reach a plateau in bone density improvement after about 2 to 3 years of therapy. However, Prolia has shown a consistent increase in bone density throughout the treatment period due to its unique mechanism of action compared to other medications. “Prolia has been confirmed to be easy to administer and continuously increase bone density through long-term clinical studies. According to presentations at various conferences, including the Korean Society for Bone and Mineral Research, Prolia’s data repeatedly indicate that it offers superior long-term improvement in bone density and reduction in fracture risk than conventional treatments,“ Professor Dempster said. “While existing treatments are good options, it may be necessary to recognize that better therapies have been developed. I hope that in Korea, there will be a growing understanding that Prolia's effectiveness is superior to conventional treatments, like that in the United States,” he added. A sequential treatment regimen is recommended for osteoporosis…concerns for the disease awareness Osteoporosis is a condition in which bone density (BMD) decreases, leading to structural damage to the bones themselves. Therefore, after restoring bone density to a certain level using bone-forming agents, maintaining the increased bone density with bone resorption inhibitors is proposed as an appropriate treatment method. In this context, sequential therapy, which involves appropriately utilizing currently available treatments rather than single therapies, is being proposed. The American Society for Bone and Mineral Research (ASBMR) recommends sequential therapy as a treatment guideline, and the Korean Society for Bone Metabolism has also adopted similar guidelines. “Treatment is essential for both high-risk and very high-risk fracture groups, but for those in the very high-risk category, considering initial treatment with bone-forming agents like Evenity or teriparatide can be an option,“ Professor Dempster said. “Bone-forming agents have approved indications for a treatment duration of 1 to 2 years, so switching to bone resorption inhibitors like Prolia or bisphosphonate agents is recommended after a certain period of treatment.“ “Clinical studies like ARCH for Evenity and comparative studies of teriparatide with risedronate have confirmed that sequential therapy using bone-forming agents followed by bone resorption inhibitors provides more effective prevention against fractures in patients,“ he added. Professor Dempster also expressed his hope that improvements in reimbursement criteria would shift awareness regarding osteoporosis treatment in South Korea. Patients with chronic conditions such as hypertension and diabetes are well aware of their blood pressure or blood sugar levels and understand the need for lifelong medication. However, understanding conditions like osteoporosis is notably lower, so individuals may not even realize they have osteoporosis. “Korea is experiencing rapid aging, with an estimated half of the population expected to be 65 or older by 2070. Therefore, starting osteoporosis treatment and reducing the risk of fractures through this treatment is crucial," he said. "Instead of blaming patients for discontinuing treatment arbitrarily, verifying the reasons for discontinuation and appropriately explaining how significant and severe the consequences could be important,” Professor Dempster said. “Efforts in the field, including expert persuasion of the government, have contributed to creating an environment for continuous treatment, even for patients with T-scores between -2.5 and -2.0. Osteoporosis cannot be fully recovered, like lifelong diseases such as diabetes and hypertension, so management is currently the best approach. I request that relevant government departments continue to listen to the voices of experts in the field,” Professor Dempster emphasized.
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- "Allowing switching between atopic dermatitis treatments"
- by Hwang, Byung-woo Jul 05, 2024 05:49am
- More options became available with the approval of biologics and JAK inhibitors to treat atopic dermatitis. However, limitations in switching treatments have been indicated to make effective treatments difficult. Opinions have been suggested that the Korean government must follow the global trend as foreign countries do not limit switching between biologics and JAK inhibitors for treating moderate-to-severe atopic dermatitis. Han Tae-young, Professor of Nowon Eulji Medical Center (Insurance Director at the Korean Atopic Dermatitis Association)During a press conference hosted by Abbvie, titled 'Press conference for the latest Rinvoq value for atopic dermatitis,' on July 3rd, Professor Han Tae-young of Nowon Eulji Medical Center (Insurance Director at the Korean Atopic Dermatitis Association), emphasized the need for switching between treatments. Switching treatments has become a persistent issue in clinical practice for atopic dermatitis due to increasing treatment options and a growing number of patients. Concerns have been raised about fairness in comparison to psoriasis, another area in dermatology where switching treatments is more possible. "Few countries among major nations limit reimbursement for switching therapies. In South Korea, reimbursement is not available for switching between biologics and JAK inhibitors, posing challenges for effective treatment.," Han stated. Typically, the efficacy of atopic dermatitis treatments is assessed based on the Eczema Area and Severity Index (EASI)-75 achievement rate. Currently approved treatments show varying efficacy levels: some achieve up to 80% efficacy by the 52-week mark, while others demonstrate 60% or lower efficacy, indicating variability depending on the patient. "Various treatments are available for atopic dermatitis, but in cases where there is no response, some patients may not experience any benefit," Han said. "Atopic dermatitis is a condition with heterogeneous characteristics that requires finding the proper treatment for each patient. However, this process can be hindered if switching treatments is not allowed." Presented by Professor Han Tae-young at the press conference on July 3rd.Until now, the Health Insurance Review and Assessment Service (HIRA) and the Korean Atopic Dermatitis Association have discussed switching between treatments. However, no progress has been made due to a lack of evidence. Recently, revising guidelines in domestic and major countries indicates a positive change. They have mentioned the latest guidelines from major countries such as the United States and Europe for switching treatments, thereby increasing the possibility of switching treatments. The 2024 guidelines updated by the American Academy of Dermatology, notably the first update in a decade since 2014, strongly recommend biologics and JAK inhibitors for the treatment of moderate-to-severe atopic dermatitis. They also include recommendations for switching therapies if initial treatments fail. "It is recommended that switching to other biologics or JAK inhibitors be considered in cases of inadequate treatment response or when the treatment cannot be used due to side effects," Han mentioned. When switching between treatments for atopic dermatitis was initially discussed, there was insufficient evidence based on guidelines. However, there are increasing expectations as switching between treatments is mentioned. Han explains that the HIRA increasingly anticipates supplementary data from the Korean Atopic Dermatitis Association regarding switching between treatments as the situation evolves. "To establish evidence, the association plans to gather patient data showing favorable treatment outcomes through switching therapies, even in cases where they are not covered by insurance," Han said. "They intend to present this data to support their initiative. However, predicting an exact timeframe is challenging, considering the detailed information requested by the HIRA."
