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Company
Baxter and Fresenius Medical benefited the most
by
Nho, Byung Chul
Jul 07, 2023 05:43am
As the Ministry of Health and Welfare's pilot project for home management of peritoneal dialysis patients began in earnest, the sales of Baxter and Fresenius Medical, which supply related products, are also expected to grow exponentially. As of 2022, total domestic hemodialysis patient medical expenses amounted to 2,634 billion won, of which peritoneal dialysis accounted for 4-5%. According to the hemodialysis adequacy evaluation data in 2018, the number of hemodialysis patients in that year was 90,901, and it is showing an increasing trend of 10,000 each year, which is difficult to find worldwide. The annual cost of hemodialysis per patient who visits the hospital's artificial kidney room for treatment is about 30 million won, and peritoneal dialysis, which can be treated at home, is observed to be 20-30% cheaper. Therefore, the health authorities plan to reduce the proportion of hemodialysis, which costs astronomical costs, and induce peritoneal dialysis to induce financial soundness, considering the health insurance financial deficit and reduction in reserves. According to what is known, health authorities are planning various policies/systems to raise the rate of peritoneal dialysis from less than 5% to a maximum of 10-20% through this pilot project. The health insurance benefit subsidy for cassettes, hemo-vacs, and catheter tip occluders, which are consumables required when using an automatic peritoneal dialysis machine, is 14.2 million won per day. Previously, the subsidy (5,640 won per day) was not enough to purchase only a cassette, but the burden of patients was reduced by expanding the benefits for Hemo-vac. Automated peritoneal dialysis is when a patient connects an automatic peritoneal dialysis machine, dialysis solution, and body catheter before going to bed, and dialysis is automatically performed while sleeping. For this reason, while there are few restrictions on work, school life, and social activities, there is a risk of accidents such as secondary infection as the patient handles all processes directly. This is a part that can be sufficiently prevented with proper education. Hemodialysis requires direct visits to the artificial kidney room three times a week for dialysis for 3 to 4 hours a day, and emergency response can be swift. Still, it has the disadvantage of being restricted in daily life. The pilot project for home management of peritoneal dialysis patients was adopted by order of the Ministry of Health and Welfare in December 2019, and the second pilot project (May 2022-2025) is currently underway. The purpose of the project is to continuously manage at-home patients and provide feedback to reduce unnecessary medical expenses due to hospitalization and worsening of diseases and to improve the quality of life of patients. The target is a chronic kidney disease stage 5 patient who needs renal replacement therapy and has agreed to participate in the pilot project for home management of peritoneal dialysis patients.
Company
Vabysmo’s real-world data to hold leader Eylea in check
by
Jung, Sae-Im
Jul 06, 2023 05:39am
The competition between the current lead ‘Eylea’ and the new drug ‘Vabysmo’ is fierce in the macular degeneration treatment market. Based on the real-world data that demonstrated Vabysmo’s consistent effect on patients who switched from Eylea, the company built evidence for patients to switch to Vabysmo. To defend the lead, Eylea’s company has attempted to release a high-dose version of Eylea but has been experiencing difficulties due to its delayed introduction. According to industry sources on the 5th, the global real-world data on Vabysmo was recently published in the international journal ‘Nature.’ The results of the investigator-led trial that was published are the first real-world data that provides a glimpse of what kind of effect Vabysmo can bring to the field.. Roche’s bispecific antibody Vabysmo (faricimab) is a new drug approved in Korea for the treatment of macular degeneration. The current leader in this market is Bayer and Regeneron’s ‘Eylea (aflibercept).’ One thing to note was that a significant proportion of the patients included in the real-world study were those that had been previously treated with ‘Eylea.’ 337 of the 376 eyes of 335 patients that participated in the study had been previously treated with an anti-VEGF agent, 237 eyes of which were treated with Eylea. Patients in the study switched to Vabysmo due to non-response or to extend their treatment cycle after using Eyelea. The other 39 eyes were treatment-naive eyes. The primary endpoints of the study were the changes in best-corrected visual acuity (BCVA), changes in central subfield thickness (CST), and safety, and the Secondary outcome measures included treatment intervals and the presence of retinal fluid. Results showed that after a single injection of Vabysmo, the mean CST reduction in previously-treated eyes was -25.3μM, and this mean value became -26.3μm in patients who were previously treated with Eyela. All patients treated with Vabysmo, including those with treatment-naïve eyes, demonstrated a mean reduction in CST of -31.3μm. Also, a number of patients demonstrated complete resolution of intraretinal fluid (IRF), subretinal fluid (SRF), or pigment epithelial detachment (PED). Patients demonstrated further improvement after 3 injections of Vabysmo. In the 337 eyes that switched to Vabysmo, the mean BCVA increase from baseline was +2.7, and the mean CST reduction of -38.1μm. Patients that switched from Eylea to Vabysmo demonstrated a mean BCVA increase of +2.2 letters, and a mean CST reduction of −42.6μ from baseline. The anatomical outcomes in the study showed that Vabysmo improved 17.8% resolution of IRF, 36.6% resolution of SRF, and 11.1% resolution of PED in patients that switched from another drug. Patients that switched from Eylea showed a 12.3%, 37.2%, and 3.2% resolution of IRF, SRT, and PED, respectively. The reduction or removal of retinal fluid from the use of Vabysmo is analyzed to have affected the maintenance and improvement of visual acuity. Two cases of intraocular inflammations were reported in the 376 eyes treated in the study, and their vision returned to baseline after treatment. ◆ Eylea faces difficulties with Vabysmo chasing at its tail Based on the real-world results, Roche is expected to speed up targeting Eylea’s share. Currently, Eylea has an overwhelming lead in the domestic macular degeneration treatment market. According to the market research institution IQVIA, Eylea recorded annual sales of KRW 80.4 billion last year. This is a 14% increase from 2021. Eylea accounted for 64% of the total macular degeneration treatment market (KRW 126.3 billion). Therefore, all the new drugs released to the market are targeting Eylea’s share, attempting to take a piece of the pie before Eylea’s patent expiry and the entry of its biosimilars. In Korea, Vabysmo entered the market this year, following ‘Beovu’ in 2020. In just 2 years of its release, Beovu posted KRW 16.5 billion in sales last year. In particular, the new entrant Vabysmo has been considered a strong contestant against Eylea because after administering the initial 4 doses at 4-week intervals, and then, Vabysmo can be administered every 16 weeks (4 months) if there is no disease activity. Many patients with macular degeneration often give up treatment due to the fear of receiving an injection in the eye, therefore extending the dosing interval was considered an important task in treatment development. And the new contestant improved the convenience of patients with a 16-week dosing interval. Eylea’s dosing interval can be extended up to 16 weeks if the patient’s disease is well managed, but the drug is administered every 4 weeks for the first 3 months and then every 8 weeks. However, Eylea has the advantage of being able to flexibly take the treatment interval depending on the patient's condition, from 4 weeks to 16 weeks. In the global market where Eylea and Vabysmo had already taken place, Vabysmo has been rapidly increasing its market share. According to Roche's earnings report, Vabysmo’s global sales in Q1 this year were CHF 432 million (approximately KRW 620 billion). When considering how the drug was approved in the US and Europe in January and September last year, respectively, the drug has shown high growth. On the other hand, Eylea experienced a drop in sales for two consecutive quarters from Q4 last year. Bayer and Regeneron had set out to introduce a high-dose 8mg version of Eylea to defend the market. However, the companies are facing difficulties as the US FDA declined approval of the higher-dose version. According to Regeneron, the approval was deferred due to a delay in the review of a drug’s third-party manufacturer and is not because of any efficacy or safety issues related to the drug. As long as there is no problem with the drug, there is no possibility that the FDA will completely turndown its approval. However, the FDA's decision delays the release of the high-dose version and is expected to delay Eylea’s defense strategy. In Korea, the environment is still favorable for Eylea because Vabysmo has not been listed for reimbursement yet. Therefore, Eylea’s sales this year will be affected by the timing of Vabysmo’s reimbursement listing. Also, the growth of Beovu, which is being more actively used in Korea than in the global market, should be watched closely.
Company
Industry anxiously awaits reimb of SGLT-2 inhibitors
by
Jung, Sae-Im
Jul 06, 2023 05:39am
The reimbursement applications that companies of SGLT-2 inhibitors filed to receive reimbursement for their heart failure indication are expected to undergo a difficult journey. The largest barrier to their reimbursement is the concern over the enormous amount of fiscal spending the drugs will bring due to the broad target patient group. According to industry sources on the 4th, the representative SGLT-2 inhibitors ‘Forxiga (dapagliflozin)’ and ‘Jardiance (empagliflozin)’ are working to extend their reimbursement from diabetes to heart failure. Forxiga has applied for the reimbursement of its heart failure reduced ejection fraction treatment indication and plans to apply for reimbursement of its heart failure with preserved ejection fraction indication that it has recently received approval for within the month. Jardiance filed an application for the reimbursement of all types of heart failure regardless of ejection fraction. In addition to diabetes, SLGT-2 inhibitors have already risen as the ‘backbone’ drug in heart failure as well. Not only has the drugs demonstrated excellent effect in heart failure with reduced ejection fraction, but they also reduced the risk of cardiovascular death or exacerbation of heart failure in heart failure with preserved ejection fraction, an area for which no treatment option existed. The rise of the two drugs has also changed the treatment guidelines for chronic heart failure. In the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure that the 3 major heart societies in the U.S. – American College of Cardiology, American Health Association, and the Heart Failure Society of America – that was released last year, the societies gave a Class 2A recommendation for SGLT-2 inhibitors to treat heart failure with mild, reduced, preserved ejections. The Korean Society of Heart Failure also recommended SGLT-2 inhibitors to reduce hospitalization or cardiovascular death due to heart failure in patients with preserved ejection fraction, regardless of diabetes mellitus (recommendation grade 1). This is why experts have been emphasizing the need for the reimbursement of SGLR-2 inhibitors for heart failure. At the Forxiga press conference hosted by AstraZeneca Korea on the 3rd, Professor Jong-Chan Youn of the Catholic University of Korea’s Seoul St. Mary’s Hospital, said, “One out of four patients diagnosed with severe heart failure die within a year of hospitalization. This is why these patients need to use a drug that shows a clear improvement in prognosis from the beginning, which is what SGLT-2 inhibitors do. However, most outpatients do not use SGLT-2 inhibitors for their heart condition due to reluctance in using non-reimbursed treatment options. These patients then experience gradually worsening symptoms and are in dire need of improvement in their prognosis, which is why the SGLT-2 inhibitors need to be reimbursed.” The concern is NHI finances. A sizable amount of NHI finances need to be invested for their reimbursement extension to heart failure. According to the Health Insurance Review and Assessment Service, the number of patients that received treatment for heart failure exceeded 150,000 in 2021. This is a 35,000 increase from 5 years ago. The number of patients with heart failure is expected to increase further due to the rapid population aging in Korea. Seok-min Kang, President of KSHF (Professor of Cardiology at Yonsei Severance Hospital), said, “As the president of KSHF, I have actively expressed my opinion on extending reimbursement to new drugs for heart failure. However, the government’s main concern is that too much finances will be spent due to the indiscriminate use of the drugs after reimbursement. Academically, these are most definitely effective drugs, but the government is reluctant to grant reimbursement due to financial concerns.” The reimbursement of SGLT-2 inhibitors went through the same sluggish progress in diabetes as well. SGLT-2 inhibitors are only allowed reimbursement in combination with some drugs such as metformin, and even these are limited to two-drug combinations. It took 8 years of discussion and persuasion to extend reimbursement for SGLT-2 inhibitors in diabetes. The health authorities had recently discussed reimbursement of heart failure treatment, but Entresto was the only drug that was granted reimbursement extensions. The discussion ended with only a partial extension of the reimbursement standard for Entresto, a drug that is already receiving reimbursement for heart failure with reduced ejection fraction. The authorities were unable to make a decision on the reimbursement extension for Forxiga and Jardiance. Pharmaceutical companies claim that granting reimbursement of SGLT-2 inhibitors will result in the saving of health insurance finances as they will be provided at cheaper prices than existing treatments. They are referring to the price of Entresto, which is priced at KRW 1,774 per tablet. Taken twice a day, Entresto costs KRW 3548 a day. On the other hand, Jardiance (KRW 660) and Forxiga (KRW 734), which are taken once a day, are 1/5 the price of Entresto. However, unlike Entresto, which is only reimbursed for heart failure with reduced ejection fraction, SGLT-2 inhibitors treat all heart failures, therefore, their cheaper price cannot directly translate to financial savings. Also, the recent ‘4 pillars’ strategy that has been presented for heart failure combines the use of 'ARNI/ACEI', 'beta blockers', ''mineralocorticoid receptor antagonists', and 'SGLT-2 inhibitors,’ therefore, the SGLT-2 inhibitors cannot act as a direct substitute for Entresto. Adding on to the injury, Forxiga is embroiled in a drug price reduction lawsuit with the health authorities. Therefore, there also is an opinion that it would be realistically difficult to extend its reimbursement until the lawsuit is completed. Nevertheless, the societies emphasized the need for the government to actively establish comprehensive management measures for chronic diseases, including heart failure. Kang said, “As much as it is important for pharmaceutical companies and the government to reach a consensus, the government also needs to pay more attention and enable the use of good treatments for chronic conditions to be used with reimbursement.”
Company
Dongkook and GC agree to co-promote Glarzia in Korea
by
Kim, Jin-Gu
Jul 05, 2023 05:45am
On the 3rd, Dongkook Pharmaceutical and GC Biopharma announced that the two companies have signed a business agreement for the domestic sales and marketing of ‘Glarzia Prefilled Pen (insulin glargine),’ a biosimilar of the insulin injection Lantus. Glarzia is a Lantus biosimilar developed by the Indian biosimilar pharmaceutical company Biocon. Its original, Lantus, is a long-acting insulin injected once daily. Under the agreement, Dongkook Pharmaceutical has been in charge of the domestic sales and marketing of Glarzia since June. As the only domestic pharmaceutical company that sells insulin injections, Dongkook Pharmaceutical will be competing with multinational pharmaceutical companies in the market. An official from Dongkook Pharmaceutical said, “Our company sees the diabetes market as a major new growth engine in the ETC drug market. The agreement we made with GC Biopharma will provide a differentiated and competitive edge for us in the market. We will continue to actively seek ways to reinforce our strategic partnership with GC Biopharma.” Insulin injections are largely divided into two categories by function – basal and prandial insulin. The basal insulin products available in Korea include ‘Tresidba (insulin degludec),’ ‘Levemir (insulin detemir),’ ‘Toujeo (insulin glargine),’ Lantus (insulin glargine),’ ‘Basaglar (insulin glargine),’ and ‘Glarzia (insulin glargine).’ Glarzia demonstrated non-inferiority over its original Lantus in terms of efficacy and safety in the INSTRIDE 1 study that was conducted on Type 1 diabetes patients and INSTRIDE 2 study that was conducted on Type 2 diabetes patients in the US.
Company
Samsung Biologics signs 2 CMO contracts with Pfizer
by
Chon, Seung-Hyun
Jul 05, 2023 05:44am
Exterior perspective view of Samsung Biologics Samsung Biologics signed two contract manufacturing organization agreements with Pfizer. The contracts, including the largest single contract ever made that is valued at KRW 922.7 billion (approximately USD 818 million), have been successfully concluded, totaling the amount to KRW 1.2 trillion (approximately USD 1.06 billion). On the 4th, Samsung Biologics announced that it has signed a contract manufacturing agreement for pharmaceuticals with Pfizer, worth KRW 922.7 billion. This amount represents 30.7% of the recent revenue. Samsung Biologics had first signed a letter of intent for the contract manufacture of Pfizer's biopharmaceuticals worth KRW 536 billion (approximately USD 411.38 million) last month. A part of the initially agreed USD 411.38 million contract that was worth USD 218.63 was increased by USD 485.76 million to become worth USD 704.39 million. nearly doubling the overall contract. This contract manufacturing agreement is the largest single contract ever signed by Samsung Biologics. On the same day, Samsung Biologics also signed a contract to expand its existing contract manufacturing agreement it had made with Pfizer in March. Initially valued at KRW 241.0 billion, this contract was also increased to KRW 495.3 billion. The amount Samsung Biologics secured through the new and expanded contracts with Pfizer nears USD 897 million (approximately KRW 1.2 trillion). Samsung Biologics explained, "We signed a contract manufacturing agreement with Pfizer in March for a product. Under the contract, we will be manufacturing Pfizer's various biosimilar product portfolio in our recently completed Plant 4 until 2029, which includes pharmaceuticals for tumors, inflammation, and immune therapies." The total contract Samsung Biologics signed with Pfizer this year totals at USD 1.08 billion (approximately KRW 1.418 trillion). Samsung Biologics is currently operating 4 biopharmaceutical plants. Plant 4, which commenced partial operation in October of last year with a capacity of 60,000 liters, has a production capacity of 256,000 liters, marking it the largest scale plant ever. With the operation of Plant 4, Samsung Biologics will secure a total production facility capacity of 618,000 liters, along with its existing 3 plants (30,000 liters for Plant 1, 152,000 liters for Plant 2, and 180,000 liters for Plant 3). A Samsung Biologics representative said, "We are increasing long-term agreements in large quantities based on our outstanding competitiveness in securing orders. So far, we have 13 of the top 20 global big-pharma companies as clients."
Company
Samsung Bioepis launches Humira biosimilar in the US
by
Lee, Seok-Jun
Jul 04, 2023 05:37am
On July 3rd, Samsung Bioepis announced that it had released its Humira biosimilar ‘Hadlima (project name: SB5, ingredient: adalimumab) in the US through its partner Organon. Hadlima is a treatment for autoimmune diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The drug is now available in the US in two formulations – low concentration (50 mg/mL) and high concentration (100mg/mL) – and is supplied in a carton containing two pre-filled pens or two pre-filled syringes. Samsung Bioepis has received approval for its low-concentration and high-concentration Hadlima in 2019 and 2022, respectively. The drug, which is approved as Imraldi in the European Union, has been supplied in Europe since October 2018. In addition to the European market, Samsung Bioepis has been supplying SB5 to 24 markets around the globe. The company owns real-world study data on over 5,100 patients across rheumatologic, dermatologic, and gastroenterological conditions. Meanwhile, Humira raised annual sales of KRW 2.7 trillion (USD 21.2 billion) last year. Among them, the US market accounts for about 88% at KRW 23 trillion.
Company
Celltrion seeks approval for Stelara biosimilar in the US
by
Kim, Jin-Gu
Jul 04, 2023 05:37am
Celltrion announced on the 3rd that it has submitted an application for the approval of its Stelara (ustekinumab) biosimilar to the U.S. Food and Drug Administration (FDA). Its indications are the same as its original - plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, pediatric psoriatic arthritis, Crohn's disease, and ulcerative colitis. Celltrion conducted a Phase 3 clinical trial of Stelara biosimilar under the development name "CT-P43." The study evaluated the efficacy and safety of CT-P43 compared to Stelara, in 309 patients with moderate to severe plaque psoriasis aged 18 and older. According to the Phase III clinical trial results that were announced in September last year, CT-P43 demonstrated its equivalence in both efficacy and safety after 12 weeks of drug administration. Celltrion applied for the marketing authorization of Stelara's biosimilar in Europe in May, as well as the marketing approval in Korea in June. Celltrion plans to continue acquiring approvals from more countries following the U.S. application. Celltrion stated, "The application includes all indications approved for the original Stelara. We expect the biosimilar to provide treatment opportunities to more patients in the future and reduce the financial burden on the health insurance system.”
Company
Discussion on whether Vabysmo benefit is possible
by
Eo, Yun-Ho
Jul 04, 2023 05:37am
Attention is focusing on whether Vabysmo, a macular degeneration treatment, will be able to be listed on the insurance benefit list. According to related industries, it is expected that Vabysmo, a Bispecific antibody treatment in Roche Korea, will be presented to the Drug Benefit Evaluation Committee this month (July). This drug passed the Drug Benefit Standards Subcommittee in May. Vabysmo, licensed as a treatment for neovascular or wet-related macular degeneration (nAMD) and vision damage by diabetic macular edema, is a new drug with a differentiated mechanism that targets both VEGF-A and Ang-2, the main path of disease. Based on the new mechanism, it is the first intraocular injection that enables administration every 4 months (16 weeks) through licensed clinical studies, and a small number of injections can reduce the patient's treatment burden. Vabysmo is administered in the recommended dose of 6 mg (0.05 ml) into the vitreous once a month (4 weeks) for the first 4 doses. After that, nAMD patients who do not have disease activity are administered once every 4 months (16 weeks). In patients with diabetic macular edema (DME), the administration interval can be increased to four weeks, extending up to four months (16 weeks), at the discretion of the medical staff. Vabysmo proved its validity through a total of four Phase 3 studies, including clinical studies related to nAMD treatment TENAYA and LUCERNE and clinical studies related to DME treatment YOSEMITE and RHINE studies. TENAYA and LUCERNE studies are Non-inferiority trials compared to Vabysmo and Eylea in nAMD treatment. As a result of the study, Babismo treatment at intervals of up to 4 months (16 weeks) in the first year of treatment showed Eylea at intervals of 2 months (8 weeks) and treatment and a mean level of vision improvement. In the first year of treatment, about 80% of the Vabysmo administration group maintained an administration interval of more than 3 months (12 weeks). In the recently released second year of treatment, more than 60% of patients maintained a four-month (16 weeks) administration interval, which was expected to provide continuous clinical benefits to patients.
Company
Forxiga expands its benefit through heart failure
by
Jung, Sae-Im
Jul 04, 2023 05:36am
Domestic and foreign cardiac societies recommend SGLT-2 for preserving exudation rates Forxiga, a blockbuster treatment with an annual prescription of 90 billion won, has expanded its scope to the entire heart failure. AstraZeneca Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 3rd to commemorate the expansion of chronic heart failure indications, including preservation of SGLT-2 inhibitor Forxiga ejection rate. At the meeting, Yoon Jong-chan, a professor of cardiology at Catholic University Seoul St. Mary's Hospital, and Oh Jae-won, a professor of cardiology at Yonsei University Severance Hospital, led by Kang Seok-min, chairman of the Korean Heart Failure Association (Cardiology at Severance Hospital). Heart failure is divided into reduction, mild reduction, and preservation according to the heart rate. Usually, less than 40% of the ejection rate is regarded as HFrEF, 41-49% as HFmrEF, and 50% or more as HFpEF. Unlike heart failure, which reduces the rate of exudation, there has been no suitable treatment for mild reduction and preservation of exudation. Many new drugs have challenged this area but failed clinical trials. SGLT-2 inhibitors have succeeded in advancing into exudate conservation heart failure. Following last year's SGLT-2 inhibitor Jardiance, Forxiga also secured the indication this year. With the expansion of this indication, Forxiga can be used in all chronic heart failure patients, including heart failure conservation at the rate of exudation. Phase 3 DELIVER study conducted by the company is a global phase 3 clinical trial that evaluates the effectiveness of Forxiga compared to placebo in heart failure patients with a withdrawal rate of more than 40% (hardness reduction-preservation) regardless of type 2 diabetes. Professor Oh Jae-won said, "About half of the patients without a history of type 2 diabetes were included, and relatively high-risk patients were included in the clinical trial, such as those who were hospitalized or have been hospitalized for heart failure. In addition, most of the patients were using various drugs, and at the time of registration of the study, patients with an improved exudation rate of more than 40% were also registered. " As a result of clinical trials, Forxiga reduced the risk of developing complex evaluation variables evaluated as cardiovascular death or worsening heart failure (unscheduled hospitalization and hospital visits due to heart failure) by 18% compared to the placebo group. Forxiga was 23% lower than the placebo group in overall heart failure exacerbation and cardiovascular death risk, and the symptom evaluation score also improved by an average of 2.4 points over the placebo group. In a sub-analysis according to the ejection rate, Forxiga also confirmed a consistent improvement trend in the patient groups of 49% or less, 50-59%, and 60% or more. Professor Oh explained, "The results of the DELIVER study are an important basis for patients and actual clinical trials as Dapagliflozin can be considered for patients with heart failure who can be prescribed by working regardless of the exudation rate." With the performance of Jardiance and Forxiga, guidelines for treating CHF have also changed. In the 2022 revised heart failure guidelines jointly published by ACC, AHA, and HFSA, the three major cardiac societies in the United States, SGLT-2 inhibitors such as Fosiga were recommended as HFmrEF·preserved heart failure treatments (recommended level 2a). The Korean Heart Failure Society also recommended SGLT-2 inhibitors to reduce hospitalization or cardiovascular death from heart failure in patients with preserving exudation rates, with or without diabetes (recommended grade 1). Professor Yoon explained, "Furthermore, this year's ACC recommended that all patients with preserving exudation rates start treatment with SGLT-2 inhibitors in the amendment to the Expert Consensus Decision Pathway." Professor Yoon said, "Half of the patients died within five years of diagnosis, so active treatment is needed from an early stage to improve the prognosis, and SGLT-2 inhibitors have provided the basis for their role." From the left, Professor Kang Seok-min, Professor Oh Jae-won, and Professor Yoon Jong-chan Professor Kang, who headed the team, explained, "It is very meaningful that the DELIVER study confirmed the effectiveness and safety of SGLT-2 inhibitors in patients who take other drugs as well as the entire ejection rate spectrum of chronic heart failure." He added, "In the meantime, new treatment options have been limited in patients with preservation and mild reduction of exudation rates, so we hope that many patients will benefit by registering their benefits as soon as possible."
Company
Lagevrio was voluntarily withdrawn from Europe
by
Kim, Jin-Gu
Jul 03, 2023 05:47am
Merck has voluntarily withdrawn its European approval application for Lagevrio, an oral COVID-19 treatment. The pharmaceutical industry is paying close attention to whether the global supply of this drug will continue. Celltrion and Hanmi Pharmaceutical, which had already decided to produce and supply Lagevrio generics to developing countries, have withdrawn their plans. Foreign media including Reuters reported on the 28th (local time) that Merck voluntarily withdrew its application for permission from the European Union (EU) for Lagevrio, an oral COVID-19 treatment. It is an analysis that Europe is in fact stepping out of the process. The EMA-affiliated CHMP recommended banning Lagevrio approval in February this year. At the recommendation of the CHMP, Merck eventually voluntarily withdrew its application for authorization in the EU. In the pharmaceutical industry, attention is focused on whether Lagevrio's exit will spread to other countries, including the United States. Lagevrio is being supplied as a corona treatment in more than 25 countries, including Korea, the US, Japan, the UK, Australia, and China. Regarding this, Merck drew a line, saying, "This decision will not affect the use of Lagevrio in countries where licensing or approval has already been completed." Lagevrio appeared in 2022, in the midst of the Corona-19 crisis. Together with Pfizer Paxlovid, it was widely used as an oral corona treatment. However, this year, the global pandemic situation has ended and its use has declined significantly. In the pharmaceutical industry, there is an analysis that Merck has decided to withdraw from the European market due to declining marketability. It is analyzed that the lower effect compared to Paxlovid also influenced the decision to withdraw voluntarily. Lagevrio is a mechanism that inhibits viral replication. Unlike Paxlovid, which lowered the risk of hospitalization and death due to corona by 89%, Lagevrio only reduced the risk of hospitalization and death by 30%, as shown in phase 3 clinical trials. It is said that the treatment effect is low and the marketability is greatly reduced, and global demand is said to have decreased significantly. After generating $5.684 billion in global sales last year, Lagevrio's sales have plummeted this year. As a result, domestic biopharmaceutical companies that were trying to produce and supply Lagevrio generics to low- and middle-developed countries are also stepping back. Celltrion Pharmaceuticals recently passed the bill to terminate the license agreement for Lagevrio generic production at the board of directors' meeting. The company originally planned to produce Lagevrio generics at its Cheongju plant but decided to terminate the contract as the COVID-19 situation eased compared to the time of the contract. Hanmi also signed a contract to produce Lagevrio generics last year but canceled it earlier this year. Likewise, Hanmi Pharm explained that this is because demand has significantly decreased as the corona crisis turned endemic. In the pharmaceutical industry, attention is focused on alternatives to Lagevrio, which is in the process of being virtually phased out. Potential alternative drugs include Xocova, developed by Japan's Shionogi Pharmaceutical, and Xafty, which is being developed by Hyundai Bioscience. Xocova is an oral COVID-19 treatment developed by Japan's Shionogi Pharmaceuticals. Xocova is currently being supplied only in Japan with EUA. Xocova recorded sales of close to 1 trillion won in Japan for four months from November last year to March this year. The Japanese government purchased 2 million doses of Xocova for 104.7 billion yen under a supply contract with Shionogi. In Korea, Ildong Pharmaceutical started the joint development of Xocova with Shionogi Pharmaceutical. Earlier this year, Ildong Pharmaceutical applied for product approval of Xocova to the Ministry of Food and Drug Safety. The review is still ongoing after 6 months. Hyundai Bioscience is developing niclosamide, which was previously used as an insect repellent in Korea, as an oral corona treatment through drug re-creation clinical trials. In phase 2 clinical trials, it was found that the time taken for improvement of corona symptoms was shortened by 4 days. Hyundai Bioscience plans to proceed with EUA and product approval to the Ministry of Food and Drug Safety.
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