- LOGIN
- MemberShip
- 2026-05-03 22:15:19
- Policy
- Lorviqua fails to receive reimb as first-line therapy
- by Lee, Tak-Sun Jun 04, 2024 05:47am
- The reimbursement extension application for Lorviqua, a treatment for anaplastic lymphoma kinase (ALK)-positive non-small-cell cancer, has failed to go beyond the negotiation stage with the National Health Insurance Service. With the breakdown of the negotiations, the company will have to start over from the application stage for Lorviqua’s reimbursement According to industry sources, Pfizer Korea’s recent negotiations with the National Health Insurance Service for Lorviqua’s reimbursement(NHIS) fell through. Lorviqua is a treatment for ALK (anaplastic lymphoma kinase) positive non-small cell lung cancer, that was listed for reimbursement in September 2022. The drug is currently reimbursed to treat patients with advanced or metastatic ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib (brand name: Alecensa) or ceritinib (Zykadia) or Xalkori (crizotinib) as first-line ALK tyrosine kinase inhibitor (TKI) therapy, However, patients who received crizotinib (Xalkori) as a first-line ALK inhibitor may also have received alectinib, ceritinib, or brigatinib as a second-line ALK inhibitor and can use Lorviqua with reimbursement. In other words, the drug is covered as second-line or later therapy in patients who have not responded to prior first-line or first- or second-line agents. Lorviqua has become a blockbuster drug since its reimbursement, posting sales of KRW 11.7 billion last year, according to IQVIA. Pfizer has been pushing to extend Lorviqua’s reimbursement to first-line based on clinical data. In January, the Drug Reimbursement Review Committee deemed the drug's reimbursement extension adequate if the company is willing to accept a price lower than the assessed value. Since then, Pfizer has been conducting drug pricing negotiations with the National Health Insurance Service, accepting the committee's opinion. However, the negotiations fell through after the company and the government failed to reach an agreement on the terms of the risk-sharing agreement scheme, etc. As a result, the company will have to start all over again from the reimbursement application stage. At the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024), which kicked off last month in Chicago, Pfizer unveiled the 5-year follow-up data on Lorviqua showing a progression-free survival rate of 60%, which is significantly higher than the 8% in the Xalkori arm. The data showed Lorviqua’s advantage in the first-line treatment environment. However, due to its failure to receive reimbursement extensions, existing first and second-line therapies will continue to dominate Korea’s ALK-positive targeted therapy market. Pfizer is reportedly planning to reapply for reimbursement as soon as possible.
- Company
- Indication for rare cancer drug Retevmo is expanded
- by Son, Hyung-Min Jun 04, 2024 05:47am
- The indication for Retevmo, which targets a rare disease mutation in lung cancer, has been expanded to include children with solid tumors across the spectrum. Retevmo is approved in South Korea for lung cancer but not reimbursed in Korea. It will be interesting to see if the additional confirmation of clinical efficacy will have an impact on its insurance reimbursement progress in Korea. According to industry sources on the 1st, the U.S. Food and Drug Administration (FDA) expanded the approval for Retevmo, a treatment targeting the RET (REarranged during Transfection) gene mutation, for pediatric patients with thyroid cancer and solid tumors for which there are no treatment alternatives. As a result, Retevmo became the first targeted therapy for pediatric patients with RET-mutant cancers under the age of 12. This is an accelerated approval and is subject to further confirmatory clinical studies to determine full approval. In addition to the existing RET-mutant lung cancer indication, Retevmo is now available for pediatric patients with RET-mutant metastatic medullary thyroid cancer, RET-mutant radioactive iodine-refractory advanced or metastatic thyroid cancer, and RET-mutant locally advanced or metastatic solid tumors for which there are no alternative treatment options during or after systemic therapy. The expanded approvals were based on the Phase I/II LIBRETTO-121 trial, which assessed Retevmo in 25 patients aged 2-20 with advanced or metastatic RET-activated solid tumors who had little response. The primary endpoints were overall response rate (ORR) and duration of response (DOR). Results showed a confirmed ORR of 48%, as determined by a blinded independent review committee. The median duration of response (DOR) was not reached and 92% of responders had responses lasting 12 months. In terms of safety, the most common adverse events were musculoskeletal pain, diarrhea, headache, nausea, vomiting, coronavirus infection, abdominal pain, fatigue, pyrexia, and bleeding. The most common grade 3 or 4 adverse reactions were calcium decrease, hemoglobin decrease, and neutropenia. Sustained responses were observed in pediatric and young adult patients with RET-mutated pheochromocytoma. The most common adverse reactions reported were musculoskeletal pain, diarrhea, headache, nausea, vomiting, COVID-19, abdominal pain, fatigue, pyrexia, and hemorrhage. The most common grade 3 or 4 laboratory abnormalities were decreased calcium, hemoglobin, and neutrophils. Retevmo makes slow domestic reimbursement progress Currently, Retevmo is making slow reimbursement progress in Korea. In May last year, Retevmo was recognized for its reimbursement adequacy by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee, but since failed to negotiate drug prices with the National Health Insurance Service and remains unreimbursed. In particular, with Roche's RET mutant-targeted therapy Gavreto withdrawn from the market, Retevmo is the only drug in the market but is not easily administrable due to its non-reimbursed status. In Korea, Retevmo is approved for the treatment of▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. NSCLC patient with RET mutation is classified as a rare cancer. RET mutations occur in 2 to 6 % of all NSCLC cases and are more often found in adenocarcinomas and younger patients under 60 years of age and non-smokers. In NSCLC, RET fusions occur more than RET mutations. In thyroid cancer, RET fusions are reported in up to 40% of the cases. While there are several treatments available for EGFR-mutant lung cancer, including Tagrisso, Leclaza, and Rybrevant, Retevmo remains the only option for RET-mutant lung cancer. Therefore, it will be interesting to see if Retevmo, which has expanded its indications to pediatric thyroid cancer and solid tumors, can play an active role in Korea.
- Company
- Evolution of ADCs… Enhertu prolongs OS in solid tumors
- by Son, Hyung-Min Jun 04, 2024 05:47am
- The antibody-drug conjugate (ADC) anticancer drug Enhertu has demonstrated further efficacy across multiple solid tumors, including HER2-low breast, biliary tract, and head and neck cancers. With the clinical results, the company secured momentum to add more solid tumors to Enhertu’s already established breast, gastric, and non-small cell lung cancer indications. Enhertu is Daiichi Sankyo and AstraZeneca’s ADC anticancer drug. Enhertu is a next-generation ADC that combines a monoclonal antibody with the same structure as trastuzumab, which binds to a specific target receptor overexpressed on the surface of cancer cells, and a topoisomerase I inhibitor payload with a tumor-selective cleavable linker, a novel and highly potent mechanism of action. Enhertu has been recognized for overcoming the limitations of existing therapies and is effective across solid tumors, not for just a single indication. Enhertumakes strides in HER2-low breast cancer According to industry sources on the 3rd, additional clinical data on Enhertu was presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024) that is being held in Chicago, U.S. On the 2nd, results from the DESTINY-BREAST06 trial, which demonstrated the additional benefit of Enhertu in HER2 low-expression breast cancer, were presented at ASCO 2024 (Source: ASCO 2024 lecture capture) The clinical trial evaluated the efficacy and safety of Enhertu in patients with HR-positive, HER2-low or HER2-ultralow advanced or metastatic breast cancer whose disease progressed following one or more lines of endocrine therapy. The HER2-low arm included immunohistochemistry (IHC) 1 or 2/fluorescent in situ hybridization (ISH) negative patients, and the ultra-low-expression arm included IHC 0 patients. The participants were randomly assigned 1:1 to receive either Enhertu or the investigator’s choice of chemotherapy (capecitabine, nab-paclitaxel, or paclitaxel). The primary endpoint is PFS in the HR-positive, HER2-low patient population as measured by a blinded independent review committee (BICR). Key secondary endpoints include PFS by BICR in the overall trial population (HER2-low and HER2-ultralow), OS in the HER2-low patient population, and OS in the overall trial population. Other exploratory endpoints included objective response rate (ORR) and safety. Study results showed that the median PFS with Enthertu was 13.2 months in the HER2-low cancer patient population, which was longer than the 8.1 months in the chemotherapy arm. The difference was also evident in the HER2-ultralow patient population. PFS was 13.2 months in the Enhertu arm versus 8.3 months in the chemotherapy arm. In patients with HER2-low expression, the confirmed objective response rate (ORR) was 56.5% for Enhertu versus 32.2% with chemotherapy, and in patients with HER2-ultralow expression, the confirmed ORR was 61.8% versus 26.3%, respectively. The OS data were immature. The researchers concluded that "Enhertu could become a new standard of care for patients with hormone-positive breast cancer following endocrine therapy in the metastatic setting.” Demonstrated prolonged survival in head and neck, biliary, and pancreatic cancers Enhertu has also demonstrated survival benefits in head and neck, biliary tract, and pancreatic cancers. The DESTINY-Pantumor02 trial verified Enhertu’s efficacy in patients with previously treated pancreatic, ovarian, cervical, bladder, biliary, endometrial, or other tumors. Based on the trial results, Enhertu’s indication was expanded across HER2 solid tumors for which there are no treatment alternatives. The study presented at ASCO 2024 is a follow-up to DESTINY-Pantumor02 in head and neck, biliary tract, and pancreatic cancers. The Phase II study evaluated the efficacy of Enhertu in patients with locally advanced, metastatic HER2-positive head and neck cancer following systemic therapy. The primary endpoint was ORR; secondary endpoints included DOR, PFS, disease control rate (DCR), and safety; and exploratory endpoints included efficacy outcomes by HER2 expression. At the time of data cutoff (June 2023), 24 patients with head and neck cancer were evaluated, resulting in an ORR of 41.7% for Enhertu. Median DOR was 22.1 months and the median PFS was 12.4 months. Safety was consistent with known safety profiles. In the DESTINY-Pantumor02 subgroup analysis, Enhertu also showed promise in pancreatic and biliary cancers. In this study, Enhertu achieved a primary endpoint ORR of 22.0% and a median PFS of 4.6 months. These results are paving the way for Enhertu to expand its indication across all solid tumors with HER2 expression.
- Company
- 'Jemperli,' a PD-1 inhibitor immunotherapy lands in Big 5
- by Eo, Yun-Ho Jun 04, 2024 05:46am
- GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab). 'Jemperli,' the first immunotherapy for endometrial cancer, has landed in Big 5 general hospitals. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has cleared the Drug Committee (DC) of the nationwide medical institutes, including Samsung Medical Center in Seoul, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. After being listed for reimbursement in December, Jemperli is now readily available for prescription. The efficacy of Jemerli was demonstrated through cohort A1 analysis results of the GARNET study. GARNET was a multiple cohort, open-label study, including patients with recurrent or advanced solid cancer. Cohort A1 enrolled patients with recurrent or advanced dMMR/MSI-H endometrial cancer who have shown progression after platinum-based systemic chemotherapy. Notably, the size of Cohort A1 was the largest among PD-1 inhibitor monotherapy studies involving patients with dMMR/MSI-H endometrial cancer to date. The study’s primary endpoints were objective response rate (ORR) and duration of response (DOR), and these were assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria Solid Tumors (RECIST). The analysis of 108 patients at 16.3 months, a median value of the follow-up period, Jemperli showed consistent anti-tumor activities and a manageable safety profile. The treatment group had ORR of 43.5%, and its DOR has yet to reach the median value. A disease control rate (DCR) of 55.6% was recorded, and 97.9% and 90.9% of the patients had treatment responses that continued for 6 months and 12 months, respectively. Meanwhile, an expanded indication for Jemperli in combination with platinum-based chemotherapy was approved for the first-line treatment of patients with advanced or recurrent DNA Mismatch Repair Deficient/Microsatellite Instability-High (dMMR/MSI-H) endometrial cancer. Jae-Hoon Kim, Professor of the Department of Obstetrics and Gynecology at Gangnam Severance Hospital, said, "Platinum-based chemotherapy has been used as the first-line standard therapy for advanced or recurrent endometrial cancer, but the patients had unmet needs due to poor prognosis, with the average of overall survival period being less than three years. Therefore, we have high hopes for the clinical significance of Jemperli for the first-line treatment."
- Policy
- Takeda’s Zejula Tab receives marketing authorization in KOR
- by Lee, Hye-Kyung Jun 03, 2024 05:49am
- Takeda Pharmaceuticals’ poly ADP-ribose polymerase Inhibitor ‘Zejual (niraparib)’ has been granted marketing authorization in Korea in its tablet form. The Ministry of Food and Drug Safety (MFDS) approved Zejula Tab 100 mg on the 31st. Like its capsule formulation, Zejula Tab is indicated ▲as monotherapy for adult patients with ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response (partial or complete response) to first-line platinum-based chemotherapy; ▲ as monotherapy for adult patients with platinum-sensitive recurrent high-grade serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have responded (partial or complete response) to two or more lines of platinum-based chemotherapy. Its capsule formulation, Zejula Cap had been approved in Korea in 2019 as the first PARP inhibitor for use in patients regardless of BRCA mutations. Patients only need to take two 100 mg tablets once daily, making it the only once-daily treatment available for ovarian cancer. In a pivotal clinical study, Zejula demonstrated a significant improvement in median progression-free survival (mPFS) compared to placebo in patients with and without BRCA mutations. Among patients with ovarian cancer who have BRCA mutations, patients treated with Zejula had a mPFS of 21.0 months, which was 4 times longer than the 5.5 months confirmed in the placebo arm. In patients without BRCA mutations, mPFS with Zejula was 9.3 months, compared with the 3.9 months in the placebo arm, a clinically significant difference. In the U.S., Zejula is an "all-comer" that is reimbursable for all ovarian cancer patients, but in Korea, it is only available as first- and second-line maintenance therapy for patients who showed response to platinum-based chemotherapy. In April, a proposal to extend Zejula’s reimbursement as first-line maintenance therapy cancer to cover HRD-positive patients in addition to the current BRCA mutation-positive patients for unresectable ovarian cancer was submitted to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee, but rejected due to its unclear reimbursement adequacy. Meanwhile, Zejula and Lynparza (olaparib) are the only PARP inhibitors in Korea with an indication for maintenance therapy for ovarian cancer.
- Company
- AbbVie’s Rinvoq is reimbursed for Crohn's Disease in KOR
- by Son, Hyung-Min Jun 03, 2024 05:49am
- Byong Duk Ye, Professor of Gastroenterology at Asan Medical Center, Rinvoq’s reimbursement has been extended to cover Crohn's disease and ulcerative colitis in Korea. With this reimbursement extension, Rinvoq became the first and only JAK inhibitor that is reimbursed to treat adults with moderate-to-severe Crohn's disease. The treatment has been shown high effect not only in controlling symptoms but also in mucosal healing, which is expected to increase its use. On the 31st, AbbVie Korea held a press conference at the Sofitel Ambassador Seoul Hotel in Jamsil to celebrate the reimbursement of Rinvoq for adult patients with moderate-to-severe active ulcerative colitis and Crohn's disease in Korea. Rinvoq is a Janus kinase (JAK) inhibitor developed by AbbVie and indicated for ulcerative colitis, Crohn's disease, atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis. In Korea, the drug became reimbursable for the treatment of patients with moderate-to-severe ulcerative colitis who have had an inadequate response or intolerance to conventional therapies such as corticosteroids, 6-mercaptopurine or azathioprine, or for whom these agents are contraindicated. It is also reimbursable for the treatment of patients with moderate-to-severe active Crohn's disease (Crohn's Disease Activity Index (CDAI) of 220 or greater) who have had an inadequate response or intolerance to conventional therapies In addition to ulcerative colitis and Crohn's disease, RInvoq is covered for the treatment of moderate-to-severe active rheumatoid arthritis in adults, moderate-to-severe active ankylosing spondylitis in adults, and severe atopic dermatitis in adults and adolescents. Inflammatory bowel disease (IBD) is a chronic inflammatory condition characterized by abnormal immune responses in the intestinal tract and recurrent episodes of inflammation caused by both internal and external factors. Typical IBD describes 2 main conditions, ulcerative colitis and Crohn's disease. These disorders are characterized by recurrent gastrointestinal symptoms such as diarrhea, bloody stools, and abdominal pain that significantly interfere with daily life, due to which patients who have been unsuccessfully treated have been expressing a dire need for effective new treatment options. In clinical trials, RInvoq has demonstrated rapid symptom control as well as mucosal healing. In a Phase III trial studying its effect in ulcerative colitis, Rinvoq demonstrated significant improvements in histologic-endoscopic assessments, including endoscopic improvement, histologic improvement, and histologic-endoscopic mucosal improvement over placebo. In the two induction studies, RInvoq demonstrated endoscopic improvement at week 8 in 36% and 44% of patients, compared with the 7% and 8% shown in the placebo arm of the two studies, respectively. In the maintenance studies, up to 62% of the patients treated with Rinvoq for 52 weeks achieved endoscopic improvement. The onset of clinical response occurred as early as Week 2 in the induction therapy study, with a higher percentage of patients achieving clinical response at Week 2 in the Rinvoq treatment arm compared to the placebo arm. Rinvoq also demonstrated significant improvements in endoscopic endpoints, including endoscopic response and mucosal healing, compared to placebo In a Phase III trial on Crohn's disease, In two induction studies, endoscopic response rates were 35% and 46% at Week 12, compared with 4% and 13% in the placebo group. In the maintenance studies, RInvoq also improved endoscopic response and remission over placebo. Byong Duk Ye, Professor of Gastroenterology at Asan Medical Center, said, “If inflammatory bowel disease is not treated properly, complications such as fistulas and perforations can occur, and the risk of colorectal cancer can increase. Many treatments have been introduced to the field, but they have been lacking in terms of mucosal healing and ease in administration." "Rinvoq has shown high efficacy in mucosal healing as well as symptom control in clinical trials. Also, its once-daily dosing is convenient for the patients. We are excited to be able to provide patients with a more effective treatment option with the reimbursement extension. Rinvoq is a drug that has also been verified in the real world."
- Company
- 'Dupixent,' the final stages of reimb expansion for children
- by Eo, Yun-Ho Jun 03, 2024 05:48am
- Sanofi Korea’s Dupixent (dupilumab) Dupixent is about to enter the last hurdle of expanding insurance reimbursement coverage for young children. According to industry sources, the Ministry of Health and Welfare (MOHW) has recently ordered drug pricing negotiations for Sanofi Korea’s Dupixent (dupilumab). Consequently, a tug-of-war between the government and Sanofi is about to start. Dupixent is covered by reimbursement for severe atomic dermatitis over the age of 6 years. If it completes the drug pricing negotiations and secures expanded reimbursement, prescriptions will become available to infants six months and above. This indication was approved in South Korea in November 2022. There have been talks about the unmet needs of Dupixent’s reimbursement expansion toward young children. Notably, the Severe Atopic Dermatitis Association (SADA) issued a statement urging the coverage of Dupixent for young children aged 6 months to younger than 6 years with severe atopic dermatitis. 85-90% of atopic dermatitis manifests symptoms at the age of five, and for severe cases, the disease persists until adulthood and relapses. However, treatments approved for children under the age of five are limited to topical treatments, and the patients with symptoms uncontrolled with topical treatments have limited treatment options due to long-term skin retractions and infection risks. Meanwhile, Dupixent demonstrated its efficacy towards young children through the LIBERTY AD PRESCHOOL Phase 3 trial. This study evaluated the efficacy and safety of Dupixent in patients aged 6 months to younger than 6 years with atopic dermatitis who have inadequate responses to topical treatment. At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group. Consequently, it met the primary efficacy endpoint. Furthermore, 53% of patients accomplished EASI-75, the secondary endpoint, in the Dupixent plus TCS combination therapy group, significantly higher than the 11% in the placebo group. Dupixent plus TCS combination therapy also improved the WSI-NRS (Worst Scratch and Itch Numerical Rating Scale) score by 49.4% compared to the placebo group’s 2.2%, demonstrating significant improvements in the common symptom of itchiness in atopic dermatitis.
- Company
- Thrombocytopenia treatment market rises as blue ocean
- by Nho, Byung Chul Jun 03, 2024 05:48am
- The prescription market for idiopathic (immune) thrombocytopenia treatments is expected to grow exponentially with the recent reimbursement standard extension granted in Korea. Until now, reimbursement for oral immune thrombocytopenia drugs has been limited to patients with immune thrombocytopenia who are refractory to corticosteroids and immunoglobulins after splenectomy or are refractory to corticosteroids and immunoglobulins and have medical contraindications to splenectomy. However, as of next month, the current reimbursement standards that require 'splenectomy' will be changed, and the oral drug will be available for use upon just the diagnosis of the disease, which is expected to expand the prescription market. Currently, Novartis' Revolade Tab (eltrombopag olamine) and Kyowa Kirin’s Romiplate (romiplostim) lead the market. The total market for both oral and injectable drugs is about KRW 15 billion based on last year's drug distribution results, and both treatments have been recording an upward-sloping sales curve. Revolade’s sales in 2020·2021·2022·2023·2024 1Q had been KRW7.5 billion·KRW 7.9 billion·KRW8.5 billion·KRW 9 billion·KRW 2.2 billion, respectively. Romiplate’s sales had remained in the KRW 1.3 billion to KRW 2 billion band from 2020-2021-2022, then grew 150% in 2023 to surpass KRW 5 billion. In 1Q 2024, its sales reached KRW 1.6 billion, closely following the performance of Revolade, which reached KRW 2.2 billion. In addition, JW Pharmaceuticals and Handok Pharmaceuticals are expected to receive approval for their Tavalisse (fostamatinib) and Doptelet (avatrombopag), which are new oral treatments for idiopathic (immune) thrombocytopenia in the third quarter of this year, further expanding treatment options. Immune thrombocytopenia is an autoimmune disease in which the body's immune system attacks platelets as foreign antigens. Serious bleeding has been reported in 9.5% of affected adults, and the patients are at 1.3 to 2.2 times higher risk of death due to cardiovascular events, infectious diseases, and serious bleeding than the general population. Also, at least half of the patients experienced fatigue and decreased mental, emotional, and physical health, as well as reduced quality of social functioning. The disease can affect many aspects of the lives of patients and their families, rendering school, work, relationships, and sometimes even daily life difficult.
- Company
- Growing DME market…new drugs clinical trials·biosimilars
- by Son, Hyung-Min May 31, 2024 05:52am
- Korean pharmaceutical companies are challenging the market for diabetic macular edema treatments with oral formulations. Handok and Curacle confirmed effects in clinical trials for oral diabetic macular edema treatments. Because only injectables are available in the market, oral formulations can have a competitive edge because of their convenience of administration. Furthermore, Korean pharmaceutical companies are set to compete in the market with biosimilars to Eyelia. According to industry sources on May 29th, positive results were secured from novel candidate product RZ402’s Phase 2 trials for diabetic macular edema conducted by Rezolute, Handok’s related company. This novel candidate drug works by inhibiting the overexpression of plasma kallikrein, which participates in blood coagulation. Handok owns RZ402’s marketing rights in South Korea. Diabetic macular edema (DME) is a diabetes complication that affects the central area of the retina, leading to vision deterioration and disorder. DME is a disease with damaged retinal vasculature due to increased blood glucose levels, resulting in macular fluid leaking. Conventional DME treatments are vascular endothelial growth factor (VEGFR) inhibitors, including Eylea, Lucentis, Beovu, and Vabysmo. Treatments offering the convenience of administrarion are leading the market. The intervals of administration of Eylea, the top-selling drug in the market, have been extended from once every two months to up to five months, and that of Vabysmo, an emerging competitor, can be administered once every four months. RZ402 is being developed as an oral formulation, and therefore, it has the advantage of differentiating from other treatments. This novel candidate product secured positive results from recently disclosed phase 2a trials, increasing its potential for commercialization. This research evaluated the efficacy and safety of RZ402 monotherapy (50 mg, 200 mg, 400 mg) and enrolled 94 patients with DME patients who had no prior experience with injectables or had limited therapies. The clinical results demonstrated that the RZ404 200 mg treatment group had the most improved edema, while there was no change across dosages. For the safety profile, no significant adverse reactions compared to the placebo were observed. Since the AZ402 200 mg treatment group had the most significant effect, this dosage will serve as the reference for future clinical 2b trials. Curacle, a Korea-based bioventure company, is developing an oral DME treatment CU06. The top-line results of clinical Phase 2a trials demonstrated no significant changes regarding the central subfield thickness, measured as CU06’s primary endpoint. However, significant improvements were observed in baseline in best-corrected visual acuity (BCVA), which was the secondary endpoint. In clinical trials, CU06 improved the patients’ word reading assessments within three months of administration. At 12 weeks, CU06 100, 200, and 300mg administration improved BCVA by up to 1.9, 2.5, and 2.2 letters, respectively. Notably, 300 mg treatment in the vision below 0.5 patient group improved BCVA by up to 6.6 letters at 16 weeks. Curacle signed a technology transfer licensing of CU06, excluding Asia, with Théa Open Innovation in October 2021. However, the company recently was notified of the return. Despite having the license returned, Curacle plans to continue the follow-up development since CU06 demonstrated clinical potential. Biosimilars are expected to be released…competition intensifies A significant number of Eyelia biosimilars are expected to be released. A significant number of Eyelia biosimilars are expected to be released in addition to novel oral formulations. Consequently, the competition in the market for DME is expected to intensify. Samsung Bioepis and Samil Pharmaceutical launched Afilivu, an Eyelia biosimilar, in the Korean market earlier this month. Afilivu was approved in February and completed reimbursement listing last month. In addition to these two companies, Sam Chun Dang Pharm successfully developed an Eyelia biosimilar, and Celltrion and Alteogen are also conducting clinical trials. Roche’s novel drug Vabysmo has been covered by insurance since last October and launched in the market. Vabysmo inhibits VEGF and inhibits angiopoietin-2 (Ang-2) to recover vasculature stabilization. It has the advantage of an extended effect. Vabysmo can be administered once every four months. Vabysmo’s global market sales closely match Eyelia’s. In two years of its launch, Vabysmo generated KRW 3.56 trillion in sales in the global market last year, which is over half of Eyelia’s KRW 7.8 trillion. Bayer, Eyelia’s developer, also recently introduced a high-dose formulation to defend the market. Bayer launched a product four times higher in dose than the previous 2 mg and extended the injection interval up to once every five months. Since Novartis’ Lucentis, Beovu, and Lucentis biosimilar are also seeking opportunities to expand sales, the competition in the market is expected to intensify.
- Company
- Adtralza becomes the 2nd reimbursed biological drug for AD
- by Son, Hyung-Min May 31, 2024 05:52am
- Jiyoung Ahn, Professor of Dermatology at the National Medical Center LEO Pharma Korea has launched Adtralza (tralokinumab) as the 2nd biologic drug in the atopic dermatitis market and is on its way to take on Dupixent. LEO Pharma has been emphasizing that Adtralza has a longer dosing interval after 16 weeks compared to existing therapies and is relatively cheaper, reducing the cost burden for patients. On March 30, LEO Pharma held a press conference at the Grand Hyatt Hotel in Seoul to celebrate the reimbursed launch of Adtralza. Adtralza is a biological drug that selectively targets interleukin-13 (IL-13). The drug is being reimbursed for the treatment of chronic severe atopic dermatitis in adults and adolescents from the 1st of this month. IL-13 is a key cytokine that causes signs and symptoms of atopic dermatitis, including immune dysregulation and skin barrier dysfunction, and is overexpressed in affected skin and is known to be correlated with the severity of the disease. The launch of Adtralza adds a biologic treatment option for atopic dermatitis alongside Sanofi's Dupixent, which inhibits IL-4 and IL-13. Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years and meets one of the following conditions: ▲patient received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but was unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or was unable to continue their use due to side effects’ or ▲Patients has an EASI of 23 or greater prior to Adtralza use. Adtralza’s clinical efficacy and safety were confirmed through four Phase III ECZTRA 3 and ECZTEND trials. The ECZTRA 3 trial compared Adtralza to placebo in patients 18 years of age and older with moderate-to-severe atopic dermatitis who had not responded adequately to prior topical therapy or requires systemic therapy. The primary endpoint of the trial was the Investigators' Global assessment score of 0 (clear) or 1 (almost clear) and EASI 75 (75% improvement in Eczema Area and Severity Index)at week 16. Trial results showed that the rate of patients who achieved EASI 75 at Week 16 was 56.0% in the Adtralza group, which is a clinically significant improvement compared with the 35.7% in the placebo group. Also, 38.9% in the Adtralza group achieved IGA (Investigator’s Global Assessment) 0/1 at week 16, compared with 26.2% in the placebo group. Results from the ECZTEND study, which evaluated the long-term efficacy of Adtralza, showed that 84.5% of patients had an EASI-75 at 4 years of Adtralza treatment. Adtralza was also effective in patients with difficult-to-treat head and neck atopic dermatitis. In particular, Adtralza had the advantage of being dosed once every 4 weeks after week 16, ensuring ease of administration for the patients. Jiyoung Ahn, Professor of Dermatology at the National Medical Center, said, “Although the symptoms of atopic dermatitis may not seem serious, the itching and pain that patients experience can interfere with sleep and other daily life activities. Although there are many treatment options available on the market, the number of patients with atopic flare-ups continues to increase, so various treatment options are necessary, We are excited about the increased treatment options that the launch of Adtralza brings to us healthcare providers and patients." Dong Hun Lee, Professor of Dermatology at Seoul National University Hospital, said, “Adtralza is convenient because it can be administered every 4 weeks at the discretion of the physician for patients with clear or nearly clear skin after 16 weeks of treatment. Also, its reimbursed price is lower than its competitors, which will reduce the financial burden borne by the patients."
