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- 2025-12-23 19:11:00
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- Development of Recomid generics fierce despite reeval issue
- by Kim, Jin-Gu Jun 15, 2023 05:38am
- Pic of Yuhan Corp Development of generics of Yuhan Corp’s antiulcer drug, ‘Recomid SR’ (rebamipide),’ continues to remain fierce in Korea. Despite the authorities’ notification of the reevaluation of rebamipide, generic companies are continuing to develop their generic versions as planned along with patent challenges. The rebamipide-based antiulcer drug market has been growing rapidly recently, mainly around Recomid SR Tab. This is why the industry believes that the generic companies decided to take the risk and believe that the reevaluation results will be to ‘maintain reimbursement.’ According to industry sources on the 15th, CMG Pharma received approval for a test plan to evaluate the bioequivalence of its Remipid SR tablets and Yuhan Corp’s Recomid SR tablets earlier this month. Before CMG Pharma, Pharmgen Science, Dongkook Pharmaceutical, and Withus Pharm received approval for 4 bioequivalence test plans to develop their respective generic versions of Recomid SR Tab. All have been approved after March this year. Adding up the approvals. 4 companies have received approval for 5 bioequivalence test plans in the last three months. One interesting aspect is that rebamipide is subject to reimbursement reevaluations this year. In February last year, the government announced its plans that it will reevaluate its reimbursement of rebamipide drugs. This means that all 5 bioequivalence tests for the development of Recomid generics were approved while the company was aware of the risk of 'reimbursement withdrawal’ that may arise after the reevaluations. The companies have also been attempting to evade Recomid’s patent. Thirty-three generic companies, including the four companies including CMG Pharma, filed a passive trial on the scope of rights against Yuhan Corp in June last year against Recomid SR’s formulation patent. 8 ingredients subject to reimbursement reevaluation in 2023 The industry pointed to the relevant market growth as the reason why the generic companies are continuing the development of generics for Recomid SR Tab and patent challenges despite the risk of reimbursement withdrawal. According to the market research institution UBIST, the rebamipide-based antiulcer drug market grew 19.7% YoY to reach KRW 143.1 billion last year. The market started to grow rapidly after the ranitidine issue arose in Q3 2019. As ranitidine-based antiulcer drugs were withdrawn from the market for excess NDMA (N-nitrosodimethylamine) impurities, rebamipide-based antiulcer drugs received reflective benefits. In 2020, its sales exceeded KRW 100 billion for the first time and then increased by 27.2% in 2 years until last year. Recomid SR Tabs were at the center of market growth. Recomid SR Tab was jointly developed by Yuhan Corp, GC Pharma, Daewoong Pharmaceutical, and Daewon Pharmaceutical. The existing tablet formulation was improved into a sustained-release formulation, reducing the 3 times a dosage regimen to 2 times a day. Thanks to the rapid growth of Recomid SR Tab, Yuhan Corp’s Recomid (tablet + SR tablet) has grown to become the second-largest product in the market. Last year, the total prescription amount of Recomid was KRW 6.8 billion, up 61% YoY. The industry estimated that about 80% of all prescriptions for Recomid came from Recomid SR Tab. Companies that jointly developed and released drugs with Yuhan Corp are in a similar situation. GC Pharma’s Mucotect, Daewon Pharmaceutical's ‘BIDreba’, and Daewoong Pharmaceutical's 'Mucotra' showed a 35-100% increase in prescriptions in 2022 compared to 2021, thanks to the addition of SR tablet products. Quarterly antiulcer rebamipide drug market size(Unit: KRW 100 million, Data: UBIST) An industry official said, “It seems that companies are continuing generic development in preparation for the possibility that reimbursement will be maintained even after the reimbursement reevaluation.” Judging from last year's case, the outline of the reimbursement reevaluation for rebamipide will be revealed as early as July. In the case of last year, the reevaluation results were notified to the pharmaceutical companies in July, and then the authorities received objections were received for a month in August. The final decision was made in November after a DREC meeting.
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- Samsung Bioepis emphasized the role of a similar
- by Hwang, byoung-woo Jun 14, 2023 05:38am
- As financial savings and patient benefits, such as health insurance, are emerging as major issues both domestically and globally, biosimilars that have the same effect as the original and are cheaper are expanding their presence. It is the expert's view that the effects are felt even when looking at overseas cases where active prescriptions are already being made. Samsung Bioepis held a satellite symposium at the 15th World Lupus Academic Conference, the 43rd Korean Society of Rheumatology Spring Conference, and the 17th LUPUS & KCR 2023 organized by the Korean Lupus Research Association and the Korean Society of Rheumatology, which were held at COEX on the 18th. The role of biosimilars was discussed. This symposium is the first academic discussion held by Samsung Bioepis at a domestic academic conference, and it delivered information on the current status and economic effectiveness of biosimilars in the field of autoimmune disease treatment to domestic and foreign rheumatology specialists. Biosimilars for 21 original biopharmaceuticals have been developed worldwide. Looking at the number of products approved for biosimilar sales by country, 78 in the EU, 40 in the US, 51 in Canada, 51 in Australia, 33 in Japan, and 20 in Korea. Speakers who participated in the Samsung Bioepis Symposium on this day emphasized that the use of biosimilars can lead to economic effects on the healthcare system. Dr. Aslam H. Anis, from the Graduate School of Population Health at the University of British Columbia in Canada, mentioned the need for an institutional mechanism for biosimilars to settle down under the theme of 'Economics of Anti-TNF Biosimilars'. Dr. Anis said, “Biosimilars trigger market competition, which promotes economic benefits, such as improving education for medical staff, developing new formulations, and conducting administrative procedures.” is estimated at about 30 billion euros." As an example, three anti-TNFs were selected: Infliximab, Etanercept, and Adalimumab biosimilar market penetration rates were analyzed with IQVIA data. Considering these points, it is a view that countries that are concerned about financial savings, such as health insurance, are considering expanding the role of biosimilars, and related markets will continue to grow. From this point of view, Dr. Anis believes that it is necessary to respond in line with each country's drug price policy, such as the conversion of prescriptions to biosimilars for previously treated patients, policies to maintain the price advantage of biosimilars, and periodic price re-evaluation. Dr. Anis said, “It is necessary to realize that the use of biosimilars brings economic benefits to the healthcare system.” Professor Jonathan Kay of the University of Massachusetts School of Medicine, who gave a presentation titled 'What rheumatologists should know about biosimilars before prescribing', mentioned that biosimilars can reduce treatment costs and offer various alternatives. In particular, he argues that there should be no prejudice in prescription as biosimilars are drugs that have undergone rigorous comparative analysis and clinical trial evaluation with expired patent drugs and have been approved by regulatory agencies. Professor Kay said, "FDA-approved biosimilars have equivalent efficacy and similar safety through extensive comparative analysis with the originals." It has potential social benefits.” He also explained, "Using inexpensive biosimilars can provide more people with an opportunity for effective drug treatment." "The cost savings from using biosimilars can be reinvested in research and development to develop new therapies that address unmet drug demand," he added.
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- The efficient use of CDK 4/6 needs to be discussed
- by Jun 14, 2023 05:38am
- Dr. Dennis J. Slamon presented the clinical results of NATALEE at ASCO 2023 held in Chicago on the 2nd (local time)CDK4/6 inhibitors, which were prevalent in metastatic breast cancer, have expanded their scope to early breast cancer. Following Lily Verzenio, Novartis Kisqali demonstrated the effect of adjuvant therapy after surgery through a clinical presentation this year. As the role of CDK4/6 inhibitors expands, new concerns are emerging to achieve the best cost-effectiveness. Joo-Hyeok Son, a professor of oncology at Yonsei Cancer Hospital, who met at the 'American Society of Clinical Oncology Annual Conference (ASCO 2023)' held for five days from the 2nd (local time) said, "The risk ratio (HR) of Verzenio is slightly higher than the risk ratio (HR) shown in early breast cancer. However, as time goes on, it remains to be seen whether the Kisqali group will be able to widen the difference between the control group and the control group,” he said. Although they are the same class of drugs, the clinical designs of the two drugs in early breast cancer are different in many ways. First of all, Verzenio was targeted for administration to high-risk patients with lymph node metastases. Kisqali did not limit the presence of lymph node metastasis. A relatively low-risk patient group was also included in the clinical trial. The dose and duration of administration are also different. Verzenio uses the same dose as for metastatic breast cancer, and after two years of administration, only endocrine therapy is continued. On the other hand, Kisqali lowered the dose by two-thirds and set the duration of administration to 3 years while conducting clinical trials. It appears to be intended to lower the risk of side effects by reducing the dose. Attention is focused on whether such differences in clinical design will affect the data. Professor Sohn said, "The risk ratio of the primary indicator shown by Kisqali at this conference was 0.74, which did not reach the initial result of Verzenio. The risk ratio was similar in advanced breast cancer, but slightly different results in early breast cancer." Several factors, such as condition and dose, may have had an impact." Prof. Sohn thinks that Verzenio, which has released four-year follow-up data, is in a slightly more solid position in early breast cancer. However, there is room for Kisqali to show more improved data over time. In fact, Verzenio showed a sustained effect even after the two-year administration period was over. The invasive disease-free survival (iDFS) rate of Verzenio, which showed a difference of 2.8%p from the control group at the 2-year follow-up, widened to 6.4%p at the 4-year follow-up. At 4 years, the hazard ratio was 0.66, and the improvement effect was greater than that of 0.70 a year ago. As the treatment area for CDK4/6 inhibitors expands to early breast cancer, new concerns are emerging. Representatively, the problem is how to set the patient group that can see the most CDK4/6 inhibitor effect. Some point out that CDK4/6 inhibitors improve iDFS by 2-3 percentage points over control. This means that out of 100 patients treated, only 3 patients will benefit from improvement. In fact, after the NATALEE study results were announced at ASCO, during the discussion session, "It is questionable whether the medical system can afford the cost of improving 3 out of 100 people in a situation where pharmaceutical costs alone cost 15 million dollars." told In this discussion session, another question was asked, "Is it possible to establish a group of patients who are more likely to receive the CDK4/6 inhibitor effect?" Professor Sohn also explained, “A consensus is needed on whether to prevent the recurrence of the three patients by spending about 65 billion won in a situation where the drug must be used for 2 to 3 years.” Professor Sohn predicted, "In the end, we have to find a biomarker (which can measure the effect of CDK 4/6 inhibitors), but it will not be an easy process."
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- Hanmi to examine the possibility of the Poseltinib effect
- by Chon, Seung-Hyun Jun 14, 2023 05:38am
- Hanmi Pharm is examining the possibility of new indications with new drug candidates returned by multinational pharmaceutical company Eli Lilly. Hanmi Pharmaceutical announced on the 12th that it announced the interim results of phase 2 clinical trial of three-drug combination therapy, a follow-up study of the BTK inhibitor Poseltinib, at the European Society of Hematology recently held in Frankfurt, Germany. The safety and efficacy of the three-drug combination therapy including Poseltinib in relapsed and refractory diffuse large B-cell lymphoma were confirmed. Hanmi Pharmaceutical and Genome Opinion supported it, and Professor Byun Ja-min of the Department of Hematology and Oncology at Seoul National University Hospital gave a presentation. Poseltinib is a BTK inhibitor that Hanmi Pharm transferred technology to Lilly in 2015 for up to $690 million, including a $50 million down payment. BTK inhibitors are drugs with a mechanism of inhibiting Bruton's Tyrosine Kinase protein, which plays a key role in B cell growth. Lilly returned the rights in January 2019, citing failure to prove efficacy in phase 2 clinical trials for patients with rheumatoid arthritis. In October 2021, Hanmi Pharmaceutical signed a contract with Genome Opinion to jointly develop Poseltinib. Afterward, Genome Opinion conducted a researcher-led clinical trial (GPL study) for relapsed and refractory DLBCL patients through a three-drug combination therapy combining Poseltinib, CD3xCD20 bispecific antibody Glofitamab, and immunomodulator Lenalidomide. In the interim results presented at this EHA, the research team confirmed the safety and effectiveness of GPL therapy. Of the 14 patients whose response was evaluated after the start of the clinical trial, 79% met the OR, which is the efficacy evaluation criterion. Despite the initial data, 36% of patients had CR with the disappearance of cancer cells. The safety cohort also had no specific adverse reactions. The research team evaluated that the GPL combination therapy has sufficient potential as a new treatment option for patients as it can broadly control the carcinogenesis of DLBCL compared to existing therapies. "We expect that it will be a treatment that gives new hope to relapsed and refractory DLBCL patients who have failed standard treatment, including CAR-T," said Professor Yoon Seong-soo of the Department of Hematology and Oncology at Seoul National University Hospital, coordinator of the entire clinical trial. said, “As the safety and effectiveness of Poseltinib and bispecific antibody combination therapy have been confirmed, we expect that the final clinical results will provide new treatment options to medical staff in the future.”
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- Hanmi's NASH drug candidate, designated as a fast track
- by Jun 14, 2023 05:38am
- A researcher at Hanmi Pharm is conducting research on new drug candidates. (Photo: Hanmi Pharm)Hanmi Pharmaceutical announced on the 13th that Efinopegdutide, a new drug candidate for non-alcoholic steatohepatitis (NASH), has been designated as fast-track by the US Food and Drug Administration (FDA). Efinopegdutide is a dual agonist that simultaneously activates the GLP-1 receptor, which helps the secretion of insulin and suppresses appetite, and the glucagon receptor, which increases energy metabolism. The technology was transferred to MSD in August 2020. This fast-track designation was led by MSD. Fast Track is a system to expedite the screening of new drug candidates being developed targeting diseases with high unmet medical demand due to lack of treatment. Phase 2a clinical trial of Efinopegdutide, which was designated as a fast-track this time, was recently completed. MSD plans to orally present the results of phase 2a clinical trial of Efinopegdutide in adult patients with NAFLD at EASL, which will be held in Vienna, Austria from the 21st (local time) to the 24th. In addition to the phase 2a clinical trial, MSD plans to initiate an additional phase 2b clinical trial for Efinopegdutide within this month.
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- Will a new treatment option be introduced for gastric cancer
- by Jung, Sae-Im Jun 14, 2023 05:38am
- Unlike lung cancer and breast cancer, gastric cancer has been regarded as one type of cancer that has not benefited from the development of new anticancer drugs. For the past decade, chemotherapy has been the standard first-line treatment for patients with HER2 gene-negative metastatic gastric cancer. This means that there were no suitable new drugs other than HER2-targeting anticancer drugs available for its treatment. However, changes have recently occurred in the treatment of gastric cancer. The immuno-oncology drug ‘Opdivo’ emerged as a first-line option, another immuno-oncology drug 'Keytruda' also obtained positive results. A targeted therapy that targets a new protein is also expected to enter the market. Two noteworthy studies in the field of gastric cancer were presented at the ‘2023 ASCO Annual Meeting (ASCO 2023)’ that was held for 5 days from the 2nd (local time). The two were: results from the Phase III trial of ‘zolbetuximab,’ a targeted anticancer drug that targets CLDN18.2 (Claudin 18.2), and results from a Phase III trial that reviewed the first-line treatment of Keytruda in gastric cancer. Primary endpoint results of Phase III GLOW trial on zolbetuximab (Data: ASCO) Zolbetuximab is a new drug being developed by Astellas that targets CLDN18.2 for the first time among anticancer drugs. Claudin 18.2 is a protein mainly present on the surface of gastric cancer cells. Although the protein is also present in normal cells, it is expressed at high levels in certain malignant tumors. Claudin 18.2 is known to be involved in the proliferation, differentiation, and metastasis of cancer cells. The GLOW clinical trial that was announced this year, compared zolbetuximab + CAPOX (capecitabine + oxaliplatin) combination therapy with just CAPOX in 507 patients with advanced·metastatic gastric cancer who were CLDN18.2 positive. Of those involved, 78% had a PD-L1 combined positive score (CPS) less than 5. Min-Hee Ryu, Professor of Oncology at Asan Medical Center The primary endpoint, median progression-free survival was significantly higher - 8.2 months - in the zolbetuximab group compared with the 6.8 months in the placebo group (HR=0.69). At 24 months, the PFS rate in the zolbetuximab group was 14%, twice higher than the 7% in the placebo group. The secondary endpoint, overall survival (OS) was 14.4 months in the zolbetuximab group and 12.2 months in the placebo group, demonstrating a 23% reduction in risk of death with zolbetuximab (HR=0.77). In addition, the objective response rate was 53.8% and the duration of response was 6.3 months in the zolbetuximab group. During an interview with Dailypharm, Min-Hee Ryu, Professor of Oncology at Asan Medical Center, said, “Zolbetuximab is expected to bring a positive effect as it has demonstrated superiority in OS as well as PFS. In terms of side effects, although the frequency of nausea and vomiting, which was different from those of existing drugs, was high with zolbetuximab, but appears to be at a manageable level. I believe the side effects arise because the targeted claudin protein is also present in normal cells.” Another noteworthy clinical trial is the Phase III KEYNOTE-859 that was conducted to evaluate Keytruda’s effect as a first-line treatment for gastric cancer. This clinical trial is significant in that MSD succeeded in changing the design of the KEYNOTE-062 clinical trial, which had previously failed in the first-line, and was led by Korean medical staff. The clinical trial compared Keytruda with the chemotherapy CAPOX or 5-FU (5-fluorouracil) to chemotherapy alone in patients with HER2-negative gastric cancer. The trial also measured the therapy’s effect according to the patient’s PD-L1 CPS score. The primary endpoint was overall survival (OS). Primary endpoint results of KEYNOTE-859 study on Keytruda as first-line therapy in gastric cancer (Data: ASCO) Trial results showed that the median overall survival (OS) of the Keytruda group was 12.9 months, reducing the risk of death by 22% compared with placebo (HR=0.78). Keytruda’s effect increased with the increase in CPS. The hazard ratio was 0.83 in the patient group with a CPS score of 1 to 10, and the hazard ratio was 0.64 in the patient group with a CPS score of 10 or more. This means that in patients with a CPS score of 10 or higher, Keytruda lowered the risk of death by 35%. In addition, the Keytruda group demonstrated significant efficacy in secondary key endpoints as well, including PFS. Sun-Young Rha, Professor of Oncology at Yonsei Cancer Hospital, Another immuno-oncology drug, 'Opdivo,' had proven its efficacy in patients with a CPS score of 5 or higher and obtained an indication for the first-line treatment of gastric cancer. Although Keytruda succeeded in demonstrating its effect later than Opdivo, it is meaningful as the results included PD-L1 CPS 1-4 point patients. Sun-Young Rha, Professor of Oncology at Yonsei Cancer Hospital, said, “The fact that Keytruda showed an improvement with a hazard ratio of 0.83 even in patient groups that include patients with CPS 1 to 4, demonstrates that patients with a CPS of 1 or more may use the immunotherapy.” They agreed that it will become necessary to devise an effective treatment strategy according to the CPS score when zolbetuximab is introduced in the future. Professor Ra said, "Our task for the future in gastric cancer is to reach a consensus on how to treat patients who are both CLDN18.2 positive and PD-L1 positive." Professor Rhu added, “There is some overlap between the areas for the use of zolbetuximab and immuno-oncology drugs. in patients with CPS between 5 to 10, the effects of the two drugs are likely to be similar, so the side effect aspect should be considered. For those with a CPS of 10 or higher, immuno-oncology drugs are definitely more effective."
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- Rozanolixizumab has been designated as an orphan drug
- by Eo, Yun-Ho Jun 14, 2023 05:37am
- Rozanolixizumab, a new drug for generalized myasthenia gravis, has been designated as an orphan drug. The Ministry of Food and Drug Safety recently announced that it designated UCB's gMG treatment Rozanolixizumab as an orphan drug. The target indication is the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive and require additional therapy with corticosteroids or non-steroidal immunosuppressants. This drug was designated for expedited review by the U.S. FDA in January and is currently undergoing approval procedures in Japan. Rozanolixizumab is a type of monoclonal antibody for subcutaneous injection that targets the emerging Fc receptor (FcRn) and has proven its effectiveness through phase 3 clinical trials. Myasthenia gravis is a rare disease that affects about 5 per 100,000 people, and can occur in people of all ages. In children and the elderly, symptoms of decreased muscle strength are caused by diseases of the immune system. In 60% of patients with this disease, symptoms begin in the eye muscles. In particular, ptosis, in which the eyelids droop, and double vision, in which objects are seen twice, may occur. Systemic myasthenia gravis is an unpredictable chronic autoimmune disease, and as autoantibodies that induce the onset can target specific proteins in the postsynaptic membrane and impair synaptic transmission in the neuromuscular junction, major countries are developing candidates. It is designated as an expedited review target and orphan drug. Looking at the current status of myasthenia treatment development, Argenx's Efgartigimod alfa has obtained US FDA approval. Nipocalimab from Johnson & Johnson is also close to commercialization. In addition, Batoclimab, which received technology transfer from Hanall Biopharma, a domestic company for Immunovant, also completed phase 3.
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- Ildong makes initial lead in the SGLT2·DPP4 combo market
- by Kim, Jin-Gu Jun 14, 2023 05:35am
- Pic of Qtern, Zemidapa, Esgliteo, and Sugadapa (clockwise from the upper left corner) Full-fledged competition has begun in the ‘SGLT-2 inhibitor+DPP-4 inhibitor’ two-drug combination therapy market for the treatment of diabetes. In the first month after 5 products were launched, outpatient prescriptions reached KRW 300 million, and AstraZeneca and Ildong Pharmaceutical's Qtern led the market bringing in prescriptions of KRW 200 million. This market is expected to expand further after the term expires for Januvia (sitagliptin) in September. Fierce competition is expected after the 86 generic companies release their two-drug combination of dapagliflozin + sitagliptin at the same time after September. According to the market research institution UBIST, SGLT-2i+DPP-4i two-drug combination therapies have posted KRW 300 million in outpatient prescription sales in May this year. The government had extended insurance reimbursement to cover three-drug SGLT-2i+DPP-4i+metformin combinations in April. With the approval, pharmaceutical companies have been applying for the reimbursement of their SGLT-2i+DPP-4i two-drug combination therapies. As of May 1st, 5 products, ▲Chong Kun Dang’s Exiglu-S Tab (dapagliflozin+sitagliptin); ▲AstraZeneca’s ‘Qtern Tab (dapagliflozin+saxagliptin); ▲Boehringer Ingelheim’s Esgliteo Tab (empagliflozin+linagliptin); ▲MSD’s Stegluzan Tab (ertugliflozin+sitagliptin); ▲LG Chem’s Zemidapa (dapagliflozin+gemigliptin), were listed for reimbursement. Front-line hospitals and clinics have been prescribing these products by adding the single-agent metformin to the two-drug combinations. In the first month after reimbursement listing, Qtern recorded the most prescriptions with sales of KRW 192 million among the 5 newly listed products. Zemidapa followed with KRW 66 million, and then Exiglu-S with KRW 22 million. Monthly prescriptions of Esgliteo and Stegluzan were less than KRW 20 million. The variable in the market is the coming entry of its latecomers. Over 90 companies will engage in competition by the end of the year. Dong-A ST’s Sugadapa (dapagliflozin+evogliiptin) has already entered the competition this month. Sugadapa was listed for reimbursement from the 1st of this month. Dong-A ST started the sale of its product in May without reimbursement in advance to offset the weakness of entering the market a month later than its competitors. With the addition of Dong-A ST, the number of competitors in this market has expanded to 5 domestic companies and 3 multinational pharmaceutical companies. In addition to LG Chem, Chong Kun Dang, and Dong-A ST are exclusively marketing their products. On the other hand, Boehringer Ingelheim has signed an agreement with Yuhan Corp to co-promote and sell its drug, and MSD with Chong Kun Dang. AstraZeneca’s Qtern is exclusively sold in Korea by Ildong Pharmaceutical. Also, many generics are expected to join the market from September this year. Generic companies are expected to release generics of the dapagliflozin+sitagliptan combination at the same time after Januvia's patent expires in September. 86 pharmaceutical companies have currently received approval for their generic versions of dapagliflozin+sitagliptan. The patent term for dapagliflozin (Forxiga), another drug, had expired in April. Daewoong Pharmaceutical's combination drug that contains its Envlo (enavogliflozin) is also expected to be released next year. Daewoong Pharmaceutical is developing a combination drug with Zemiglo (gemigliptin) to combine with its Envlo. Daewoong Pharmaceutical plans to release its combination product by Q1 next year. Some are predicting that the SGLT-2 inhibitor + DPP-4 inhibitor two-drug combination will not produce as good results as expected. As the addition of metformin is required for the reimbursement of the two-drug combination, the criticism is that the advantage of convenience in intake offered by combination drugs has faltered somewhat. In fact, prescriptions with the new products have no significant difference from the previous prescriptions that added a single DPP-4 inhibitor to SGLT-2 inhibitor+metformin two-drug combinations. Therefore, industry analysis is that the SGLT-2 inhibitor+metformin combination, which was previously released in bulk with Forxiga's patent expiry, will become mainstream in the prescription market.
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- Discussions on expanding benefit for Jakavi's GVHD are slow
- by Eo, Yun-Ho Jun 13, 2023 05:43am
- Discussions on expanding insurance coverage for Jakavi's Graft-versus-Host Disease (GvHD) indication have been sluggish. According to the industry, Novartis Korea Jakavi passed the harmaceutical Reimbursement Criteria Subcommittee of the Health Insurance Review and Assessment Service last February, but it has not been submitted to the Financial Impact Assessment Subcommittee, which is a step before the Pharmaceutical Reimbursement Evaluation Committee. In May 2022, after obtaining indications for graft-versus-host disease in Korea, the drug submitted an application for an extension of coverage. However, after being put on hold for more than 8 months, discussions on salary have begun. GvHD is a serious complication that can occur after an allogeneic hematopoietic stem cell transplant (allo-SCT). The transplanted donor's T cells recognize the patient's normal cells as foreign substances and attack them, affecting various organs such as the skin, gastrointestinal tract, liver, and lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantation and affects their quality of life. Steroids are used as the first-line therapy, but about 50% of them fail, and in these cases, standard treatment has not yet been established, so there is an unmet demand for effective treatment options. Jakavi is an option for the treatment of patients with acute or chronic graft-versus-host disease aged 12 years or older who do not respond adequately to prior corticosteroid therapy in these circumstances. Kim Hee-jae, chairman of the Korean Society for Hematopoietic Stem Cell Transplantation (Professor of Hematology at Seoul St. Mary’s Hospital), said, “Jakavi has shown good effects through clinical studies in the treatment of acute and chronic patients, and similar results have been shown in actual practice. “It opens up new possibilities for many patients,” he said. Jakavi has proven its efficacy in GvHD through the phase 3 REACH2 study. As a result, the overall response (OR) on day 28 of the Jakavi-administered group was 62% (96/154), which was higher than that of the control group, Best Available Therapy (BAT)-administered group, 39% (61/155). On the 56th day, the durable overall response was confirmed to be 40% (61/154), about twice as high as 22% (34/155) of the control group. More about this source texture text is required for additional translation information.
- Company
- Severe asthma Tx Tezpire to soon be commercialized in Korea
- by Eo, Yun-Ho Jun 13, 2023 05:43am
- The new drug for severe asthma, ‘Tezpire' is soon to enter the Korean market. According to industry sources, AstraZeneca Korea has submitted an application for the approval of ‘Tezspire (tezepelumab)’ in Q2 to the Ministry of Food and Drug Safety and is receiving review. At this pace, Tezspire is expected to be commercialized in the second half of the year. As a viable competitor to Sanofi’s ‘Dupixent (dupilumab),’ Tezspire inhibits the action of the thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades, to block the inflammatory chain reaction. The drug was approved by the US FDA in 2021 as a treatment for adult and pediatric patients aged 12 years and older with severe asthma., and added a self-injection formulation to its approval in February this year. Tezspire demonstrated a significant reduction in asthma exacerbation in the Phase II PATHWAY trial and Phase III NAVIGATOR trial, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status, and fractional exhaled nitric oxide (FeNO). The most common adverse reactions shown in those that received Tezspire in the trials were pharyngitis, rash, arthralgia, and injection site reactions. The findings from the NAVIGATOR study were previously published in The New England Journal of Medicine. The Korea National Enterprise for Clinical Trials had selected Tezspire as the No.1 drug in need of an urgent introduction to Korea in its report on the ‘List of foreign new unintroduced drugs that should be promptly Introduced to Korea.’
