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- 2026-04-08 16:59:23
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- HK Inno.N will copromote Xigduo and Sidapvia with AZ
- by Kim, Jin-Gu Feb 01, 2024 12:38pm
- HK Inno.N and AstraZeneca Korea announced on the 31st that they held a signing ceremony at HK Inno.N's Seoul office to mark their strategic collaboration of their diabetes portfolio. Under the agreement, HK Inno.N will jointly market and sell Xigduo (dapagliflozin + metformin) and Sidapvia (dapagliflozin + sitagliptin) with AstraZeneca Korea. HK Inno.N had signed a co-promotion agreement for Sidapvia in October last year. The co-promotion agreement was expanded this time to include Xigduo. At the same time, the company will be responsible for the domestic supply and distribution of the single-agent drug ‘Forxiga.’ At the end of last year, AstraZeneca Korea decided to withdraw Forxiga from the Korean market, and HK Inno.N will be responsible for the domestic supply of Forxiga until the second half of this year. Both companies assured that they will fully commit to ensuring a stable supply for patients using Forxiga, including those with type 2 diabetes, chronic heart failure, and chronic kidney disease, so they do not experience any inconvenience. HK Inno.N has previously been in charge of the domestic sales of Dong-A ST’s Suganon series for 5 years. Based on the market understanding and know-how accumulated through the experience, the company plans to focus on marketing and sales of Xigduo and Sidapvia at general hospitals, semi-general hospitals, and clinics. Dalwon Kwak, CEO and President of HK Inno.N, said, “Building on the strong network and co-marketing experience HK Inno.N owns in the diabetes market, we will focus our sales and marketing capabilities to ensure that AstraZeneca's excellent treatments are stably supplied to healthcare providers and patients in Korea, We will make our best efforts to supply the drugs we co-market through healthcare providers in general hospitals and clinics nationwide and establish the drugs as solid treatment options for patients with type 2 diabetes in Korea. Sewhan Chon, Country President of AstraZeneca Korea, said, “Through our partnership with HK Inno.N, AstraZeneca Korea will continue to work to drive the expansion of the diabetes combination market and provide various treatment options for patients and healthcare providers in Korea. In particular, we will do our utmost to ensure a stable supply of Forxiga in Korea so that patients with type 2 diabetes, chronic heart failure, and chronic kidney disease do not experience any inconvenience.” Sidapvia is manufactured in Korea under an agreement between AstraZeneca and SK Chemicals. As the Marketing Authorization Holder (MAH) for Sidapvia, AstraZeneca is responsible for its commercialization in Korea and abroad, while SK Chemicals is responsible for the manufacture and supply of the product. According to the market research institution UBIST, prescriptions for Xigduo amounted to KRW 47.2 billion last year, up 2% YoY. Sidapvia posted sales of KRW 200 million last year.
- Company
- 13 of Keytruda’s indications await ‘redeliberation’
- by Eo, Yun-Ho Feb 01, 2024 12:38pm
- The first result for the reimbursement for the remaining 13 indications of Keytruda was ultimately a collective ‘hold.’ However, the reimbursement journey for 'Keytruda' has just begun. The Health Insurance Review and Assessment Service held its first Cancer Disease Deliberation Committee meeting of the new year on January 31st and reviewed the reimbursement of the remaining 6 indications for MSD Korea's PD-1 inhibitor immuno-oncology drug Keytruda (pembrolizumab) that were not reviewed last year, and issued another re-deliberation decision. This completes the first round of reviews for Keytruda’s 13 indications for which the company applied for reimbursement in June last year. 3 indications were presented in October, 4 in November, and 6 in the most recent CDDC meeting. At the time, MSD applied to extend reimbursement to 13 indications for its Keytruda. The indications were: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer,▲persistent, recurrent, or metastatic cervical cancer,▲ advanced endometrial carcinoma, ▲advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer A re-deliberation decision is not a rejection. It literally means that the agenda will be given a second look. MSD Korea had applied for a large-scale reimbursement expansion for its Keytruda, which was an unprecedented event in the history of Korea's insurance benefits system. Due to its large scale, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, which are conducting the review, also need to take their time for serious deliberation and preliminary discussions. In other words, the first re-deliberation decision was probably inevitable. It would be more accurate to say that the first review was more of a preliminary review of the medical validity and necessity of reimbursing the 13 indications. In fact, MSD appears to be quickly preparing for the redliberation process. A company official said, "Through the first round of discussions, we completed discussions on the need for the reimbursement and clinical utility of Keytruda’s 13 indications. MSD will now focus on building on the discussions made during the 3 rounds of deliberations and prepare additional measures to expand reimbursement, including a fiscal-sharing plan.”
- Company
- MSD’s rare cancer drug Welireg first prescribed in KOR
- by Eo, Yun-Ho Jan 29, 2024 06:05am
- A rare anti-cancer drug targeting a very small number of patients, Welireg, has been prescribed in Korea. According to industry sources, the prescription code for MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan),’ has been registered at the Samsung Medical Center in Seoul. Currently, SMC is the only hospital that has the drug code inserted for Welireg’s prescription in Korea, and the first patient was prescribed the drug in December last year. Welireg was designated as an orphan drug in January for the treatment of Von Hippel-Lindau disease and was officially approved in May. Specifically, the drug is indicated for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. Welireg’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 VHL-associated RCC patients diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the trial, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders who were still responding after at least 12 months was 56%. Median TTR was 8 months. Also, in patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%. Meanwhile, the drug has recently been approved for renal cell carcinoma in the U.S. The drug demonstrated its efficacy in the LITESPARK-005 trial, which was conducted on 746 patients with unresectable locally advanced or metastatic clear cell RCC that had progressed following both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI. Results showed that Welireg improved progression-free survival in advanced RCC following treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor-targeted therapy compared with the everolimus, and reduced the risk of disease progression or death by 25%.
- Company
- Vemlidy dominates stagnant 300 bil. won hepatitis B market
- by Son, Hyung-Min Jan 29, 2024 06:05am
- The market for hepatitis B treatment, worth 300 billion won annually, is currently experiencing a slowdown. While Gilead Sciences Korea’s Vemlidy is expanding its market share, Viread and Baraclude are facing a decline. In the generics market, Dong-A ST is leading the market. Prescription sales for Vemlidy has increased by 26% compared to last year, while original drugs have shown poor performance According to the drug market research agency UBIST on the 26th, the market size for hospital outpatient prescriptions last year was 284.6 billion won, a 1.2% increase compared to 281.1 billion won in 2022. Additionally, the market size for original drugs last year was 236 billion won, showing a slight increase from 229.2 billion won in 2022. The size of the hepatitis B treatment market. (Unit: KRW 100 million) Vemlidy is experiencing rapid growth in the market for treating hepatitis B. The original drug's sales have significantly decreased since Viread’s drug pricing reduction in 2018, and Vemlidy seems to be filling the void. Vemlidy entered the Korean market in 2017. In 2019, its prescription sales exceeded 10 billion won, and the sales continued to grow, with 39.3 billion won in 2021 and 49.2 billion won in 2022. The prescription sales of Vemlidy recorded 61.9 billion won last year, a 25.8% increase compared to the previous year. Vemlidy, a new hepatitis B drug developed by Gilead Sciences, is a follow-up to Viread. Despite its effectiveness in inhibiting the hepatitis B virus, Viread is known to cause side-effects such as kidney injury and low bone mineral density. If any problem arises with kidney function after receiving treatments, reimbursement standards allow Vemlidy to be replaced by Baraclude. Vemlidy overcomes Viread's adverse effects. In clinical trials, Vemlidy treatment demonstrated effectiveness in the long-term treatment of patients and observed no side effects related to kidney injury or low bone mineral density. Considering that hepatitis B cannot be cured, the safety of long-term administration is crucial to both patients and medical professionals. Gilead Sciences is switching Viread, its first marketed hepatitis B drug, with Vemlidy. Changes in prescription performance of key hepatitis B treatment drugs. (Unit: KRW 100 million) Prescription sales of Viread were 164.7 billion won in 2018, but they have been declining since then, reaching 113.1 billion won in 2019 and dropping to 90 billion won in 2020. Last year’s prescription sales amounted to 93.5 billion won, a 1.6% decrease from the previous year. Baraclude recorded prescription sales of 73 billion won last year, indicating a 2.1% decrease from 2022. The analysis suggests that the decline in Baraclude sales can be attributed to a reduction in drug pricing. BMS Pharmaceutical voluntarily reduced the price of Baraclude, which had expired patent, as part of a trade-off approach following the listing of its acute myeloid leukemia treatment Onureg and myelofibrosis treatment Inrebic for reimbursements. Prescription sales for GSK's Zeffix decreased by 13.1% from 3.8 billion won in 2022 to 3.3 billion won last year. GSK was unable to capture the market share left by Hepsera's withdrawal. Hepsera, a new drug for hepatitis B developed by GSK, recorded over 10 billion won in prescription sales in 2018. However, about a quarter of patients experienced resistance to the drug and experienced difficulties in maintaining treatment. GSK withdrew the approval for Hepsera in 2022, leading to its withdrawal from the Korean market. Changes in prescription performance of key hepatitis B treatment drugs. (Unit: KRW 100 million) Sales of treatments from domestic pharmaceutical companies were not significant. Bukwang Pharm’s Sebivo topped prescription sales of 1.2 billion won, showing a 25% decrease from the previous year. Sebivo, a Novartis drug introduced by Bukwang Pharmaceutical in 2019, saw a decline in prescription performance even after Bukwang took over sales. Il Dong's Besivo maintained its performance by generating prescription sales of 2.3 billion won last year, holding steady compared to the previous year. Besivo has not shown significant growth since its launch in 2017. Levovir, Bukwang Pharm's in-house developed hepatitis B drug, maintained its performance from 2022 by achieving sales of 800 million won last year. Levovir, the first domestically approved hepatitis B treatment, received approval in 2006. However, its prescription sales have consistently declined, recording less than 1 billion won since 2021. Generic drug growth slowed…Decreased sales of generic versions of Viread and Baraclude Last year, prescription sales for some generic drugs were reported to have decreased, just like certain original pharmaceuticals. Generic drugs for hepatitis B recorded prescription sales of 48.6 billion won last year, showing a 6.3% decrease from 51.9 billion won in 2022. During the same period, the market share of generics also slightly decreased from 23% to 21%. Yearly prescription performance of Viread and its generic versions. (Unit: KRW 100 million) Prescription sales for generic version of Viread decreased by 6.4% from 17.1 billion won in 2022 to 16 billion won last year. Viread generic drug market has steadily increased prescription sales since surpassing 10 billion won in 2019, but its growth halted after five years. Among them, Dong-A ST's Virreal, which holds the highest market share, experienced a 12.5% decrease in prescriptions, dropping from 3.2 billion won in 2022 to 2.8 billion won. During the same period, Daewoong's Virehepa decreased by 11.8%, and Jeil Pharm’s Tecavir decreased by 15.2%. Yearly prescription performance of Baraclude and its generic versions. (Unit: KRW 100 million) Prescription sales for Baraclude's generic version were recorded at 33.3 billion won last year, a 4.5% decrease compared to 2022. Although this market surpassed 30 billion won in prescription sales in 2020, it did not significantly increase its market share. Dong-A ST's Baracle recorded prescription sales of 10.5 billion won last year, becoming the only generic drug to surpass the 10 billion won mark. In this market, Dong-A ST held a 32% market share. Bukwang Pharmaceutical's Bukwang entecavir recorded 3.2 billion won last year, a 29% decrease from 4.5 billion won in 2022. During the same period, Daewoong Pharmaceutical's Baracross increased from 3.3 billion won to 3 billion won, indicating a 9% decrease. The prescription sales for JW Pharmaceutical’s Entekhan decreased by 17%. Generic drug developers' next target is Vemlidy. Aside from the first generics like Dae Woong’s Vemliver, Dong-A ST’s Vemlia, and CKD Pharmaceutical’s Tenofobell-A, five other companies have received approval for generic versions of Vemlidy in the domestic market. These generics were officially launched in the last quarter of the previous year, contributing to a combined prescription amount of 800 million won for the quarter. It will be interesting to see how Vemlidy's growth might impact the expansion of the generic pharmaceuticals market. Due to issues related to reimbursement cuts, switching between hepatitis B treatments has been challenging. However, generic companies plan to increase their market share by offering lower drug prices. Currently, Vemlidy costs 3,500 won, but domestic generic companies have entered the market with prices in the 2,400 won range, approximately 70% of Vemlidy's price.
- Policy
- Referencing lowest A8 price will result in a supply crisis
- by Nho, Byung Chul Jan 29, 2024 06:05am
- Health authorities and the pharma-bio industry are at an impasse over the implementation of 'A8 external reference pricing reassessments.’ Engaged in a tug-of-war, the two parties have difficulty finding common grounds. The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Research-based Pharmaceutical Industry Association, have been meeting since the end of 2022 and have completed the 5th round of negotiations as of this month, but they have been unable to reach a consensus, with each being busy making mutual claims. The ‘reassessment for the A8 external reference pricing system’ was proposed to add Canada to the existing list of A7 countries (U.S., U.K., Germany, Switzerland, Italy, France, and Japan) as a detailed reference point for drug price reevaluations. During initial discussions, there was talk of expanding the number of countries to A9, to include Australia and Canada, but Australia was removed due to strong public opinion that the 2 countries with the lowest drug prices were selected to cut prices. The issue that remains in the restructured external reference pricing system is that health authorities are sticking to using the lowest listed prices among A8 countries, while the industry believes using the average of the highest listed price is best. The average and median values, excluding the upper and lower extremes and U.S. drug price, are also considered options but are not on the table. Following a comprehensive discussion process scheduled for the end of next month, health authorities are now looking to implement the program as soon as 2025 after an appeal process in the middle of this year. Initially, the A8 external reference pricing system was planned to be applied only to diabetes, hypertension, and hyperlipidemia drugs, but there always remains a possibility that it could be extended to virtually all drugs, including anticancer drugs. If the health authorities adhere to their original proposal, the ramifications of its megatonne drug price cut are self-evident. Moreover, it is likely to add fuel to the fire of essential drug supply disruptions that arose due to the unstable price of drug substances due to the aftermath of the COVID-19 pandemic and the Ukraine-Russia war. In addition, the A8 drug price reference countries do not have a large number of data submission drugs or salt-modified drugs compared to Korea, therefore major price cuts for these drugs are also expected. An industry insider said, "Following the bulk drug price reduction in 2012 and the linkage of drug prices upon fulfillment of the ‘self-bioequivalence tests-DMF registration' requirement in 2019, there is a lack of objective basis for conducting drug price cuts using reference countries overseas that is currently being planned by the health authorities. Imposing such a policy is nothing short of an invasive act against domestic medicines and could lead to a serious industry contraction." As it is common for drug prices to be determined by taking into account all the specificities of the country's economy, society, and culture, therefore, it is not common sense to use the low drug prices set in one or two countries as a reference or standard. In addition, according to some research service data, Korea's generic price is 53.55% of the original price, ranking fourth among OECD countries, so it is difficult to say that Korea has a high drug price structure. The drug price reevaluation using the A8 external reference pricing system had been sparked by a booklet that had been published by Canada’s Patented Medicine Price Review Board, which was released at the 2022 National Assembly Audit, but the booklet seems to be an intuitive interpretation that is far from a precise report, as it lacks the correction values of domestic new drug and generic drug prices at that time and now. In other words, concluding that domestic generic drug prices are higher than those of external reference countries is highly likely to cause distortions in the drug pricing system, as it does not consider how the generic drug prices were set to the high insurance drug prices the multinational pharmaceutical companies received at the time of initial listing. Another industry insider said, "There is a strong sentiment that we should expand the drug price referencing to Canada and use it as a reference point for reevaluation. If the application of the system is expanded to include new drugs introduced from abroad and homegrown new drugs, this may not only discourage R&D efforts but also deprive patients of the right to treatment."
- Policy
- Remote GMP inspections not recognized from April
- by Lee, Hye-Kyung Jan 29, 2024 06:05am
- The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures. After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (MFDS) now decided to recognize only on-site reports rather than the written reports, which had been recognized for a limited time due to difficulties in conducting on-site inspections. From April 25, the only written reports the MFDS will accept are vendor audit results from on-site inspections. In order to import active pharmaceutical ingredients (API), the company must submit a GMP certificate of API issued by the government or public institution of the country of manufacture. However, when the company seeks to receive a supply of the APIs for the manufacture of finished pharmaceutical products, vendor audit results based on an on-site inspection of the finished pharmaceutical product manufacturer are also recognized as a GMP certificate. Due to the COVID-19 pandemic, It had been difficult to conduct on-site inspections, which was why the MFDS had recognized written inspection result reports. The MFDS stated, "During the COVID-19 pandemic, it was difficult to conduct on-site inspections, which was why we temporarily recognized written inspection reports. However, with the end of the COVID-19 pandemic, we will give a 3-month grace period and then recognize only on-site GMP inspection reports from April." Previously, the MFDS had replaced GMP on-site inspections with remote inspections such as by reviewing PIC/S report data during the COVID-19 outbreak, but since September last year, it has been phasing out the flexibilities that were put in place and started on-site inspections for some items, new drugs, or aseptic preparations, conducting a phased transition back to on-site inspections. As regulatory agencies such as the U.S. and PIC/S have announced that non-face-to-face inspections cannot replace on-site inspections, the MFDS is also converting some parts of the non-face-to-face inspections back to on-site inspections.
- Company
- Will Polivy secure reimbursement approval this year?
- by Eo, Yun-Ho Jan 29, 2024 06:04am
- Roche Korea’s Polivy (polatuzumab vedotin) The question of whether ‘Polivy,’ a B-cell lymphoma treatment, will be listed for insurance reimbursements this year is garnering significant attention. According to industry sources, Roche Korea’s Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be presented to the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st. Previously, in 2021, Polivy made an initial attempt to obtain reimbursement listing for its third-line treatment as a combination therapy with BR therapy (bendamustine/rituximab). However, Polivy did not receive approval from the Cancer Disease Review Committee. In the first half of last year, Roche applied for reimbursement as a first-line treatment, in combination with other pharmaceuticals, including rituximab plus cyclophosphamide, doxorubicin, and prednisone. As the first CD79b-directed antibody-drug conjugate (ADC), Polivy received approval for its indication as a first-line treatment in Korea in November 2022. This approval was granted approval based on the demonstrated efficacy in Phase 3 POLARIX clinical trial results. The POLARIX trial conducted follow-up of all patients for more than 24 months. During the 28.2-month follow-up period, patients with DLBCL treated with first-line Polivy and R-CHP combination therapy showed a 27% reduction in the risk of disease progression or death compared to those treated with R-CHOP. Among the most commonly reported adverse reactions of Polivy combination therapy, with a frequency of more than 30%, are peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%), and diarrhea (30.8%). DLBCL, which is an aggressive form of blood cancer, is the most common type of non-Hodgkin lymphoma. In Korea, approximately 5000 patients are newly diagnosed with DLBCL every year. DLBCL falls into the category of aggressive lymphoma, which requires immediate treatment due to the fast progression of the disease. About half of the patients reach remission following treatment due to their positive responsiveness to the therapy. However, approximately 30-40% of the patients are still non-responsive to the standard therapy, R-CHOP, or experience remission after receiving first-line treatments. Most patients with relapsed or refractory DLBCL experience recurrence within two years, and the duration of survival after recurrence is estimated to be only six months. Despite these critical conditions, not many effective treatment options are available for patients with relapsed or refractory DLBCL.
- Policy
- Lilly’s UC drug Omvoh is soon to be approved in KOR
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- Lilly's ulcerative colitis treatment Omvoh (mirikizumab-mrkz) is nearing approval in Korea. Omvoh received U.S. FDA approval in October last year and settled as the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. According to industry sources, the Ministry of Food and Drug Safety recently completed a safety and efficacy review for Omvoh’s marketing authorization in Korea. MFDS’ completion of the safety and efficacy review means that marketing authorization for the drug is imminent. Omvoh is the only ulcerative colitis treatment that selectively binds to the p19 subunit of IL-we and inhibits interaction with the receptor. Ulcerative colitis is a chronic inflammatory disease of unknown cause characterized by inflammation localized in the mucosal or submucosal layers of the large intestine, and the p19 subunit plays an important role in the development of inflammation associated with ulcerative colitis. The FDA’s approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of LUCENT-1 - a 12-week induction study (UC-1) - and LUCENT-2 - a 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biological treatments, that did not work, stopped working, or that they could not tolerate. After 12 weeks of treatment with Omvoh, 65% of patients achieved clinical response and 24% achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, 99% of patients who achieved clinical remission at 1 year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least 3 months prior to the end of the 52-week assessment. In 2018, a Phase III trial for Omvoh was approved by the Ministry of Food and Drug Safety under the same details as the LUCENT program, and completed in Korea. Omvoh was approved in Japan in March and in Europe in June last year.
- Policy
- P2T for LG Chem’s obesity drug LB54640 approved in Korea
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- LG Chem’s generic obesity treatment, 'LB54640,' has been approved for a Phase II clinical trial in Korea. On the 24th, the Ministry of Food and Drug Safety approved LG Chem’s application to initiate a randomized, placebo-controlled, double-blind Phase II study with an open extension period to evaluate the efficacy and safety of LB54640 in patients with acquired hypothalamic obesity. Hypothalamic obesity is a type of syndromic obesity that results from abnormalities in endocrine, hypothalamic, genetic, frontal, and metabolic systems. It is classified as a rare form of obesity that occurs in approximately 1% of pediatric obesity patients. The Phase II study will be conducted at Seoul National University Hospital until March 1, 2025. Global clinical trials for LB54640 had previously been approved in the U.S. and Europe. LB54640 is a once-daily (oral) treatment for obesity that targets the action pathway of the MC4R (melanocortin-4-receptor) protein, which is known to deliver satiety signals. According to LG Chem, results of the Phase I study showed LB54640’s potential with up to 3% reduction in body weight in the highest-dose group over 28 days of treatment. The drug received orphan drug designation from the U.S. Food and Drug Administration (FDA) as a treatment for LEPR deficiency in September 2020 and for POMC deficiency in June 2022. Meanwhile, LG Chem signed an agreement with Rhythm Pharmaceutical to transfer the global development and marketing rights for its orphan drug LB54640 on the 5th. The agreement, which amounts to USD 350 million (KRW 400 billion), includes an upfront payment of USD 100 million (KRW 130 billion). Upon successful commercialization, the company will receive separate sales royalties based on annual sales.
- Company
- New CKD drug Kerendia lands in general hospitals in KOR
- by Eo, Yun-Ho Jan 26, 2024 05:51am
- The landing procedure for the new chronic kidney disease drug 'Kerendia' is in full swing in general hospitals in Korea ahead of its reimbursement listing. According to industry sources, Bayer Korea's Kerendia (finerenone) recently passed the drug committee (DC) review at Sinchon Severance Hospital. It is also undergoing a landing process at major hospitals nationwide. Kerendia, a treatment for chronic kidney disease associated with type 2 diabetes, will be listed for reimbursement next month (February). With Chong Kun Dang joining as a domestic sales partner, full-scale promotional activities are expected to unfold along with the rapid landing process. Kerendia was approved in Korea last year as a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. CKD is one of the most common complications of type 2 diabetes and an independent risk factor for cardiovascular disease. Although it is a progressive disease, it is difficult to detect because there are no specific symptoms until just before end-stage renal failure. In addition, when end-stage renal failure occurs, dialysis or kidney transplantation is required to maintain life, which not only imposes a significant social and economic burden but also significantly affects the patient's quality of life. Therefore, patients with type 2 diabetes need to be monitored regularly for kidney damage with kidney function tests, it is important to slow the progression of kidney disease and lower the risk of cardiovascular disease through early diagnosis and appropriate treatment. Three main factors are known contributors to kidney disease in type 2 diabetes: hemodynamic changes, metabolic abnormalities, and inflammation and fibrosis. However, current treatments primarily target hemodynamic and metabolic factors, raising the need for new therapies that target the inflammation and fibrosis factor. Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that targets inflammation and fibrosis in adult chronic kidney disease with type 2 diabetes. Overactivation of the mineralocorticoid receptors can cause inflammation and fibrosis, which can lead to permanent kidney damage. By inhibiting the overactivation of the mineralocorticoid receptor, Kerendia reduces inflammation and fibrosis and inhibits kidney damage. Bayer demonstrated Kerendia’s efficacy through the Phase III trial (FIDELIO-DKD). In the study, which enrolled approximately 5,700 patients in 48 countries worldwide, Kerendia was found to reduce chronic kidney disease progression and reduce cardiovascular disease risk in adult patients with chronic kidney disease and type 2 diabetes. Patients in the study received 10 mg or 20 mg of Kerendia or placebo in addition to standard therapy. Results showed Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo. In addition, Kerendia reduced the major secondary outcome – a composite of time to first 9 occurrences of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure – by 14%. The overall rate of serious adverse events or acute kidney injury-related adverse events was comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) published a major revision of its 2021 guidelines for the diagnosis and treatment of acute or chronic heart failure (HF), which included Kerendia as a Class 1A recommendation in preventing hospitalization for heart failure in patients with chronic kidney disease with type 2 diabetes. In addition, the ESC recommended that patients measure their glomerular filtration rate and urinary albumin levels once a year to screen for the development of chronic kidney disease in patients with diabetes.
