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- 2025-12-23 00:39:56
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- "Envlo shows superior effects in diabetic kidney disease"
- by Son, Hyung-Min Mar 21, 2024 05:52am
- Daewoong Pharmaceutical Daewoong Pharmaceutical announced on the 19th that Envlo (ingredient: enavogliflozin), an SGLT-2 class diabetes treatment from the company’s drug discovery, demonstrated superior effects in patients with diabetes compared to dapagliflozin. Based on the clinical results, Envlo has shown superior effects in all four indexes, including ▲glycosylated hemoglobin, ▲fasting glucose, ▲urine glucose-to-creatinine ratio (UGCR), and ▲homeostasis model assessment-insulin resistance (HOMA-IR), compared to dapagliflozin, another SGLT-2 inhibitor. The clinical study evaluated changes in glycosylated hemoglobin and fasting plasma glucose in 470 patients with type 2 diabetes. Based on their kidney functions, the patients were assigned to two groups and were given either Envlo or dapagliflozin for 24 weeks. The study enrolled patients with type 2 diabetes patients who had inadequate glycemic control despite undergoing a combination of metformin and another antihyperglycemic agent or a combination therapy of metformin and gemigliptin (DPP-4 inhibitor). The clinical results demonstrated that Envlo reduced fasting plasma glucose more significantly than dapagliflozin. The Envlo group had fasting plasma glucose of 26.65 mg/dl at week 6 and 28.54 mg/dl at week 24, while the dapagliflozin group had fasting plasma glucose of only 21.54 mg/dl at week 6 and 23.52 mg/dl at week 24. Envlo, a new Korea-made drug, has a superior effect in reducing ‘glucose’ than a global pharmaceutical drug…The results from the study of diabetic kidney disease patients. A significant reduction in glycosylated hemoglobin in the Envlo group was observed, with a decrease of 0.76% at week 6 and 0.94% at week 24. This indicates a nearly 1% reduction in glycosylated hemoglobin over 24 weeks. Dapagliflozin resulted in a reduction of 0.66% at week 6 and 0.77% by 24 weeks. Among the clinical result indexes, the ‘urine glucose-to-creatinine ratio’ (UGCR) particularly stands out. The UGCR measures the ‘glucose’ secretion in urine. The patients administered with Envlo had UGCR of approximately 55g/g from week 6 to week 24. This result is similar to the level seen in diabetic patients with normal kidney function. Daewoong Pharmaceutical anticipates that the new Korea-made drug Envlo will provide an outstanding alternative for diabetic patients with kidney disorders. Currently, patients who have been taking Forxiga are facing finding a new drug because the global pharmaceutical company announced the discontinuation of Forxiga. “It is of particular interest that we provide clinical evidence when diabetic patients require a new drug prescription,” Daewoong Pharmaceutical’s CEO Chang-jae Lee said. “As the clinical result was published in a globally recognized SCIE research paper, we plan to obtain additional evidence to prove Envlo as an alternative solution,” Lee added. The study was published in the SCIE-listed international research paper, ’Cardiovascular Diabetology.’ It was titled ‘Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials.’
- Company
- Haleon Korea declares full independence from GSK
- by Eo, Yun-Ho Mar 21, 2024 05:52am
- The consumer healthcare company Haleon has declared its full independence from GSK. Haleon Korea, the Korean subsidiary of Haleon, announced on the 20th that it has completed the official registration of its business and is embarking on a new journey. The company had been completely spun off from GSK in July 2022 to become a 100% consumer healthcare specialty company. In Korea, the company has been preparing for the change for the past year and a half, including changing the packaging of its products, and has finally finalized the process and has officially launched as Haleon Korea in March 2024. Haleon Korea has been selling 12 leading brands in Korea, including ▲Centrum (multivitamin brand), ▲Sensodyne (toothpaste for sensitive teeth), ▲Parodontax (toothpaste for gum health), ▲Polident (denture cleaning and adhesive brand), ▲Teraflu (cold relief brand), ▲Otrivine (nasal congestion relief brand), and ▲Driclor (hyperhidrosis management brand). Dong-Woo Shin, CEO of Haleon Korea, said, “We will continue to introduce scientifically verified products every year to empower consumers' self-care capabilities and race for the development of the Korean consumer healthcare market.” Haleon was launched in 2015 and 2020 as the combined consumer healthcare business of Novartis and Pfizer, and then GSK, respectively. The name Haleon is a combination of health and strength, inspired by the old English word "Hale," meaning health, and the Greek word "Leon," which is associated with strength.
- Company
- Fintepla gets orphan drug designation for Dravet syndrome
- by Eo, Yun-Ho Mar 21, 2024 05:52am
- UCB 'Fintepla' has been designated as an orphan drug in South Korea for its indication for Dravet syndrome. The Ministry of Food and Drug Safety (MFDS) has announced this in the posting of the Orphan Drug Designation. UCB’s Fintepla (fenfluramine) initially acquired FDA approval for the treatment of rare epilepsy of infancy in 2020. Additionally, in 2022, it added an indication for Lennox-Gastaut syndrome (LGS). Fenfluramine, banned in the United States in 1997, suppresses appetite by increasing serotonin content in the brain. It was discontinued because overuse of the drug led to the stimulation of the central nervous system, damaged heart valves, schizophrenic symptoms, and even death. Fenfluramine is currently prescribed as a low-dose and liquid form for oral administration. Randomized, double-blind, placebo-and comparator-controlled Phase 3 clinical trial, including children and adolescents aged 2 to 18, demonstrated efficacy of fenfluramine. The primary endpoint was a comparison of the monthly convulsive seizure frequency (MCSF). MCSF comparison results show that the frequency of convulsive seizure for a month in the fenfluramine group reduced by 54.0% compared to the placebo. In the fenfluramine group, 54% had a clinically significant reduction in MCSF, compared to 5% in the placebo group. The fenfluramine group had a longer median seizure-free interval than the placebo group (22 days vs. 13 days). The percentage of patients who were seizure-free after an episode was 12% in the fenfluramine group and 0% in the placebo group. Patients treated with fenfluramine had a significant reduction in convulsive seizures compared to the patients treated with a placebo. Notably, the fenfluramine group had a reduction in seizures within three to four weeks and maintained treatment effects over 14 to 15 weeks. Dravet syndrome is a rare disease characterized by tonic-clonic seizures or myoclonic seizures, which cause muscles in the body to contract and relax, during infancy. It has been reported that SCN1A gene mutations are a common cause of the disease.
- Company
- SK Life Science’s sales rise tenfold in 5 years in the US
- by Chon, Seung-Hyun Mar 20, 2024 05:44am
- SK Biopharmaceuticals' U.S.-based subsidiary posted sales of nearly KRW 500 billion last year. The sales of its epilepsy drug cenobamate increased in the U.S., increasing the company’s sales by over tenfold in 5 years. According to the Financial Supervisory Service on Tuesday, SK Life Science’s sales totaled KRW 49.9 billion last year, up 26.5% from the previous year. SK Life Science is a wholly-owned subsidiary of SK Biopharmaceuticals. It is in charge of the U.S. sales of cenobamate, a new drug developed by SK Biopharmaceuticals. Annual sales of SK Life Science (Unit: KRW 100 million, Data: FSS) SK Life Science’s sales have been showing strong growth, up 83.7% in 2 years since posting KRW 267.2 billion in 2021. Its sales have expanded more than tenfold in five years from a mere KRW 47.5 billion it generated in sales in 2018. This is in part due to the surge in sales of its new epilepsy drug cenobamate in the United States. Xcopri, which contains cenobamate, is an epilepsy drug independently developed by SK Biopharmaceuticals and sold in the United States. It is prescribed for the treatment of partial-onset seizures in adults in the U.S. Its mechanism of action relieves seizure symptoms by simultaneously regulating two targets related to excitatory and inhibitory signaling, which are causes of epilepsy. SK Biopharmaceuticals had independently performed the whole course of Xcopri’s development and commercialization from early development to U.S. Food and Drug Administration (FDA) approval. The company received approval for its cenobamate under the brand name ‘Xcopri’ in November 2019, and has been selling the drug through SK Life Science since May 2020. Last year, cenobamate’s U.S. sales reached KRW 270.8 billion, up 60.1% YoY. In 2021, cenobamate posted sales of KRW 78.2 billion, more than tripling in 2 years. SK Life Science has about 150 medical representatives. Epilepsy is a condition that is treated by a small number of focus specialists in the United States. Due to the small number of target physicians, the company was able to sell the drug directly in the U.S. with such a small sales force. SK Life Science’s marketing center, which consists of sales and marketing personnel, has experts with more than 20 years of experience in successfully launching and selling epilepsy treatments and major central nervous system drugs at Johnson & Johnson, UCB, and other leading companies in the U.S. CNS market. Quarterly sales of Xcopri in the US (Unit: KRW 100 million, Data: FSS) With the rise in cenobamate’s sales, SK Life Science’s parent company has also increased its operating expense support. Last year, SK Life Science's revenue included KRW 220 billion in operating expenses paid by its parent company SK Biopharmaceuticals. SK Biopharmaceuticals earned revenue by supplying SK Life Science with cenobamate. The company pays SK Life Science a certain amount of operating expenses each year, which are reflected in SK Life Science's revenue, according to the company. The company said, "The number of prescriptions in December last year, the 44th month of cenobamate’s launch, was about 26,000, which is about 2.2 times the number of prescriptions made in the 44th month by its competitors. We will work to accelerate growth by increasing the number of monthly prescriptions to over 30,000 this year.”
- Company
- Sales of Tagrisso stay strong, Leclaza rises in lung cancer
- by Mar 20, 2024 05:44am
- In the EGFR-positive non-small cell lung cancer (NSCLC) treatment market, Leclaza’s sales growth stood out amid strong sales of Tagrisso. Tagrisso and Leclaza are both third-generation targeted therapies, and the two were approved as a first-line treatment for lung cancer this year and were given the green light to expand sales. Among first- and second-generation targeted therapies, all drugs other than Giotrif posted sluggish sales last year. According to the market research institution IQVIA on the 20th, Tagrisso generated sales of KRW 111 billion last year, up 4.2% YoY. Tagrisso is a third-generation tyrosine kinase inhibitor (TKI) that was developed by AstraZeneca. EGFR-positive lung cancer treatments are categorized into four types: first-generation EGFR TKIs like AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib); second-generation EGFR TKIs like Boheringer Ingelheim's Giotrif and Pfizer's Vizimpro (dacomitinib); and third-generation EGFR TKIs like Leclaza (lasertinib) and AstraZeneca's Tagrisso (osimertinib). Sales of Tagrisso, which exceeded the KRW 100 billion mark in sales in 2020, have remained stagnant for 2 years. After reaching KRW 106.5 billion in 2020, the drug posted similar sales in 2021 and 2022. After working to receive reimbursement for the drug as a first-line treatment for years, AstraZeneca received the reimbursement approval this year as a first-line treatment for EGFR-positive lung cancer, and this is also expected to expand sales. Moreover, Tagrisso is also the only third-generation TKI to be approved for use in early-stage lung cancer. In December last year, Tagrisso was approved as an adjuvant therapy for patients with EGFR exon 19 and exon 21 mutated NSCLC after complete resection. In the phase III ADAURA study, Tagrisso was shown to reduce the risk of death by 51% compared to conventional therapy. Powered by the advantages, Tagrisso’s sales are expected to increase further in the coming years. Leclaza posted sales of KRW 22.6 billion last year, up 40.3% YoY. Leclaza, which was approved in Korea in January 2021, was also granted reimbursement the same year. After posting KRW 4.1 billion in sales in Q2, it posted sales of KRW 16 billion the following year, then surpassed KRW 20 billion last year. Leclaza’s approval as a first-line treatment for EGFR-positive NSCLC in July last year is analyzed to have contributed to the rise in sales. Before the approval, patients had to be confirmed to be T790M-positive through an additional tissue test after using a first- or second-generation EGFR TKI to be eligible to use Leclaza with reimbursement. With all 3 TKIs, including Leclaza and Tagrisso, now covered as first-line treatments, physicians and patients will have a full range of first- and third-generation targeted therapies to choose from. Another benefit of Leclaza is its potential for use in combination with Rybrevant. Combination therapies, including Tagrisso plus platinum-based chemotherapy and Rybrevant plus platinum-based chemotherapy, are currently approved by regulatory authorities abroad for the first-line treatment of lung cancer. Combining the use of Leclaza, which targets EGFR-mutated exon 19 and exon 21 deletion, with Rybrevant, which targets exon 20 deletion, has been attracting attention as a viable targeted therapy combination. Currently, the Leclaza + Rybrevant combination is being reviewed for approval in the US as a first-line treatment for lung cancer. Sales of all first-generation EGFR TKIS other than Giotrif decline During the same period, first- and second-generation TKIs saw sluggish growth. Only Giotrif’s sales showed growth, while all others declined. Giotrif generated KRW 27.2 billion in sales last year, up 5.8% from 2022. Since its launch in Korea in 2014, Giotrif has seen a gradual but steady increase in sales. After surpassing the KRW 10 billion mark in sales for the first time in 2017, Giotrif posted sales of KRW 16.6 billion in 2019, KRW 22 billion in 2021, and KRW 25.7 billion in 2022. Giotrif benefited how third-generation TKIs not being used as first-line treatments. On the other hand, Vizimpro’s sales had been sluggish. Vizimpro, which had been released later in 2020, had increased slightly to KRW 1.4 billion in 2021 and KRW 2.8 billion in 2022, but stagnated at KRW 2.7 billion last year. The weakness of Vizympro is in its side effects. In the ARCHER 1050 study, the Phase III trial that became the grounds for its approval, Vizympro showed better efficacy compared to first-generation TKIs, but also a higher rate of adverse events. 60% of patients in the Vizympro arm required dose adjustments due to adverse events. In general, first-generation TKIs are continuing to show declining sales. First, Iressa posted sales of KRW 12.7 billion last year, down 9.2% YoY. Sales have been on a steady decline since 2020 when sales fell below KRW 20 billion (USD 19.6 billion). Iressa posted KRW 16.7 billion in sales in 2021 and KRW 14 billion in 2022. Iressa is known to be a milder cancer drug with fewer side effects among targeted therapy options. As such, it has been used as a priority in patients with relatively poor health. However, sales have been declining with more treatment options becoming available, with latecomers confirming their efficacy over Iressa. Tarceva’s sales fell 13.8% YoY to KRW 3.1 billion last year. This is the fifth consecutive year the drug saw declining sales after posting KRW 8.2 billion in 2019. Compared to the KRW 17.3 billion it had earned in 2016, Tarceva’s sales have more than halved. Tarceva’s sales are also on a decline due to the emergence of more effective second and third-generation targeted therapies. Tarceva also suffered a setback in 2016 when its maintenance therapy indication was removed for patients with stage IIIA or higher NSCLC. Also, Tarceva was not proven effective in retrospective clinical studies. Therefore, its sales are expected to continue to decline when combined targeted therapies are approved for use in the first line.
- Company
- Professor Yoo discovers specific protein expression in HCC
- by Lee, Tak-Sun Mar 19, 2024 05:45am
- Professor Changhoon Yoo, Department of Oncology, Asan Medical Center On the 15th, CMIC Korea, a contract research organization (CRO), announced that the results of the RENOBATE (IIT, Phase II) trial led by Professor Changhoon Yoo (Department of Oncology, Asan Medical Center) were recently published in the international academic journal, Nature Medicine (IF=82.9). This is the first time the results of a clinical study conducted by a Korean researcher have been published in Nature Medicine. In the RENOBATE 42 patients with hepatocellular carcinoma were administered the immunoconology drug regorafenib in combination with the targeted anticancer drug nivolumab. The study used circulation tumor DNA and single-cell RNA sequencing analysis to identify the characteristics of immune cells expressed in patients who did not respond to the combination therapy. The recent development of immuno-oncology drugs, also known as 3rd generation anticancer drugs, that offer better anticancer effects with less toxicity and side effects, has raised hopes for many cancer patients. However, 3 out of 10 patients with HCC were either not responding to or getting worse with the use of targeted anticancer drug+immune-oncology drug combination therapy. The RENOBATE study found that these patients had more than 2 times more expression of a specific protein called TMEM176A/B. This is very promising news for HCC patients who were unable to see much effect with the use of existing anticancer therapies and raises expectations for further developments. The study, which has raised the profile of Korea’s anti-cancer research, was initiated by Professor Changhoon Yoo in 2019 with his collaborators and was completed 3 and a half years later in late 2022. Even though the study was an investigator-initiated trial, which usually has a small amount of research funding, CMIC Korea, the first clinical contract research organization (CRO) in Korea, took charge of monitoring, data management, and clinical analysis to ensure and collect accurate and ethical clinical research data. According to Professor Yoo, this has helped improve the credibility of his research, which has been recognized by peer review and Nature Medicine. This has also been mentioned in the methodology part of the paper as well. Professor Yoo said, "We will continue on our efforts to support patients suffering from incurable diseases through reliable clinical research."
- Company
- Celltrion rolls out Zymfentra in the U.S.…its 1st new drug
- by Chon, Seung-Hyun Mar 19, 2024 05:44am
- On the 18th, Celltrion announced that it had launched Zymfentra, a subcutaneous (SC) formulation of infliximab, in the United States. Pic of Zymfentra Zymfentra is a subcutaneous injection formulation of Celltrion's infliximab. The company received approval from the U.S. Food and Drug Administration last year for its use as a treatment for patients with ulcerative colitis or Crohn's disease. Zymfentra is currently approved and marketed in Europe under the brand name Remsima SS. The original infliximab product is Remicade. Zymfentra’s wholesale price has been set at $6,181 (for 2 doses, 4 weeks). A Celltrion official said, “Based on Zymfentra’s new drug status, the price of competitors in inflammatory bowel disease, and the characteristics of the U.S. pharma-biotech market, we have set an optimal price for us to carry out an effective sales strategy.” If the company’s patent applications for Zymfentra’s SC formulation and method of administration are granted and registered, the drug will receive patent protection by up to 2040. According to the market research institution IQVIA, the U.S. market for TNF-α inhibitors, which includes infliximab, has been valued at approximately KRW 62.06 trillion in 2022. The IBD market, which is the company’s area of focus for Zymfentra, had been valued at KRW 12.8 trillion. Celltrion aims to raise the prescription rate of Zymfentra to reach at least 10% of its target patient population by the second year, 2025, and establish Zymfentra as a global blockbuster that brings in over KRW 1 trillion in annual sales. Celltrion plans to sell Zymfentra directly through its U.S. subsidiary. A Celltrion official said, “Already, several small and mid-sized payers have recognized Zymfentra’s competitivity and have added the product to their formularies without negotiation, laying the groundwork to expand prescriptions.”
- Company
- New CKD drug Kerendia is reimbursed in Korea
- by Son, Hyung-Min Mar 18, 2024 05:50am
- Sunggyun Kim, Professor at Hallym University Sacred Heart Hospital (Secretary-General, The Korean Society of Nephrology) Whether the reimbursement coverage of Bayer’s Kerendia will help address the unmet needs of patients with chronic kidney disease with type 2 diabetes, is gaining attention. Until now, blood pressure medications and diabetes drugs have been used to treat chronic kidney disease, but the introduction of Kerendia has expanded the treatment options. Supported by its proven clinical efficacy, the drug is expected to be more widely used by patients with chronic kidney disease. On the 15th, Bayer Korea held a press conference to celebrate the launch of Kerendia (finerenone) for chronic kidney disease with type 2 diabetes in Korea. Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that inhibits the overactivation of mineralocorticoid receptors, which can cause inflammation and fibrosis in the kidneys and blood vessels. Overactivation of mineralocorticoid receptors causes inflammation and fibrosis in the kidneys, which can lead to deterioration of kidney function and cardiovascular disease. The drug was granted reimbursement in combination with ACE inhibitors and ARBs for adult patients with type 2 diabetes who have been taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least 4 weeks but ▲have an albumin-to-creatinine ratio (uACR) >300 mg/g or a positive urine dipstick test (1+), or ▲have an estimated glomerular filtration rate (eGFR) of at least 25 but less than 75. Kerendia’s reimbursement approval was based on the reduction in kidney disease progression, cardiovascular benefit, and safety that was demonstrated through the Phase III trials FIDELIO-DKD and FIGARO-DKD. The FIDELIO-DKD study evaluated the safety and efficacy of Kerendia compared with placebo in 13,171 adult patients with type 2 diabetes in 48 countries. Over a median follow-up of 3 years, Kerendia reduced the composite cardiovascular endpoint (cardiovascular death, nonfatal myocardial infarction, and stroke, etc) by 14%, and the renal composite endpoint (occurrence of a sustained decline in eGFR below 15 Ml for at least 4 weeks, chronic dialysis, and kidney transplantation) by 23%. Results were consistent with and without treatment with GLP-1 receptor agonists and SGLT-2 inhibitors at baseline. Kerendia also demonstrated significant risk reduction in the cardiovascular composite endpoint in the FIGARO-DKD study, which included patients with Stage I and II chronic kidney disease. Yong-Ho Lee, Professor of Endocrinology and Metabolism at Severance Hospital (Secretary General, Korean Diabetes Association), said, “We have been using GLP-1 receptor agonists, SGLT-2 inhibitors, and blood pressure medications on chronic disease patients with diabetes, but there always remained a residual risk of chronic kidney disease in the patients. SGLT-2 inhibitors do not completely reduce proteinuria, but Kerendia's efficacy, which was demonstrated through multiple clinical trials, makes the drug an important treatment option for patients with chronic kidney disease.” Sunggyun Kim, Professor at Hallym University Sacred Heart Hospital (Secretary-General, The Korean Society of Nephrology), said, “ The American Diabetes Association guidelines recommend a reduction in uACR of at least 30%, and Kerendia reduced the average uACR by 32% compared to placebo in the first 4 months of treatment. Therefore, the drug can be considered in priority for patients with kidney disease."
- Company
- NMOSD drug Enspryng can be prescribed at general hospitals
- by Eo, Yun-Ho Mar 18, 2024 05:50am
- Enspryng, a new drug for neuromyelitis optica spectrum disorder (NMOSD) is landing in general hospitals in Korea. According to industry sources, Roche Korea's Neuromyelitis Optica Spectrum Disorder (NMOSD) drug Enspryng (satralizumab) has passed the drug committees (DCs) of tertiary hospitals including Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, as well as medical institutions including the National Cancer Center, Chonnam National University Hospital, and Chungnam National University Hospital. In addition, the drug can be prescribed in an increasing number of medical institutions that inserted the drug code through emergency DC meetings to prescribe Enspryng. As such, the drug’s prescriptions have been increasing steadily after being granted reimbursement in December last year. Enspryng was approved in Korea in the first half of 2021, after which the company submitted an application for its reimbursement in the second half of 2022. However, due to its high price, the company faced considerable difficulties in setting its reimbursement standards and financial sharing plans. The company had first adopted the strategy of accepting the weighted average price (WAP) of its alternative, AstraZeneca’s ‘Soliris (eculizumab),’ but due to a delay in Soliris’s reimbursement listing process for NMOSD, the company turned to the pharmacoeconomic evaluation exemption track for its reimbursement. After switching to the PE exemption track, the agenda passed HIRA’s Drug Reimbursement Evaluation Committee in August and completed pricing negotiations with the NHIS in November of the same year. However, its reimbursement is currently limited to its use as a ‘fourth-line or later’ therapy. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate, or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as fourth or later-line therapy in patients who fail treatment with rituximab in the third-line. Therefore, it remains to be seen whether the company will seek to extend reimbursement for Enspryng after listing. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Company
- Price nego for reimb of much-petitioned Enhertu complete
- by Eo, Yun-Ho Mar 18, 2024 05:49am
- The long journey of the petitioned anticancer drug ‘Enhertu’ if finally coming to an end. According to Dailypharm’s coverage, Daiichi Sankyo and AstraZeneca Korea recently completed drug pricing negotiations with the National Health Insurance Service (NHIS) for their antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) Barring any changes, the drug is expected to be covered from next month (April). After receiving approval for Enhertu in Korea in September 2022, the companies submitted a reimbursement application for the drug in December of the same year. Although the application passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee after re-deliberations, it took 8 months afterward for the agenda to pass the Drug Reimbursement Evaluation Committee in February. With 50,000 people signing a petition and the government being questioned on the reimbursement progress repeatedly by the National Assembly, both the government and the company would have had to carry a significant burden during reimbursement discussions. When considering the limited scope of freedom the company has with regard to the drug price, the fact that Enhertu’s reimbursement passed the DREC review this time implies that the government has set the ICER threshold at least KRW 50 million. What is encouraging is the speed with which the negotiations were concluded. Considering how the drug’s pricing negotiations began late last month, the parties had reached an agreement way before the given deadline (60 days). There were certainly challenges that needed to be overcome during negotiations. Even with the extraordinary ICER threshold granted for the drug, the company would have had limitations in accommodating the set standards. In addition to the government and pharmaceutical companies' best efforts, to some extent, the quick progress may also be influenced by the political pressure ahead of general elections. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1 Enhertu, which was petitioned by 50,000 people, was presented to the Health Insurance Policy Review Committee this month and will be listed in April.
