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- 2026-04-04 07:31:06
- Opinion
- [Contribution] On MFDS’s new drug approval fee hike
- by Whang, byung-woo Nov 21, 2024 05:46am
- Kyung-won Seo, Chair Professor, Department of Food& Medical products Regulatory Policy, Dongguk University The Ministry of Food and Drug Safety recently announced a significant rise in its new drug approval fee to KRW 410 million. In Korea, the new drug approval fee had remained very low at KRW 8.83 million for decades, compared to the US FDA's KRW 5.3 billion, the European EMA's KRW 490 million, and the Japanese PMDA's KRW 430 million. The fee hike had been long desired by the industry and the MFDS alike, and the MFDS had worked hard to raise the fee. So the significant increase in the new drug review fee means that the value of the new drug review work being carried out by the authorities has been properly recognized, which the MFDS and the MFDS members in charge of new drug approvals should be proud of. Congratulations and a big round of applause to MFDS for their hard work and this long-awaited achievement. Since a new drug is a substance that has never been administered to humans before, the development company must conduct extensive experiments to confirm the quality, safety, and effectiveness of the new drug, and regulatory authorities must evaluate the adequacy of its process and results. The process of reviewing new drug data requires a large number of experts from regulatory agencies and takes more than a year, so the labor cost of this process is reflected in the new drug review fee, which renders the fee high. The industry has been receiving the news with mixed emotions – welcoming the long-awaited increase of the new drug review fee but then panicking at the unexpectedly large increase. As the industry will be paying a significant amount - KRW 410 million – it will expect high-quality regulatory services. The MFDS’s announcement of the 'Innovative Plan for New Drug Approval' along with the administrative notice of the 'Fee Regulations for Drug Approvals, etc.' is an expression of its strong will to provide high-quality regulatory services that can meet industry expectations. Until now, the biggest complaint of the industry has been the unpredictable review period/approval date of new drugs. A particularly notable part of the MFDS’s innovation plan is that it will shorten the review period from an average of 420 business days to 295 calendar days. Unlike other countries, the MFDS’s review period is calculated in working days and does not include the time spent by the company preparing the data, so the total review period was delayed by 420 days on average, even if the statutory deadline was not met. If the review period for new drugs is shortened to 295 calendar days, the Korean public will benefit by using innovative new drugs with verified efficacy and safety sooner, and the industry will receive the greatest gift of all: predictability in their approval. In order for the MFDS to meet the actual 295-day timeframe, it will need to recruit a large number of highly qualified reviewers with expertise, conduct a thorough prior review to ensure that supplemental requirements that require significant time to prepare do not arise during the review process and harmonize review regulations internationally to ensure that no data or tests are required only by MFDS. As most of the delays had occurred due to requests for supplementary data that require a significant amount of time to prepare, to prevent this from happening, a thorough preliminary review should be conducted and a system put in place to prevent the application from being accepted if it lacks required data. Once the application has passed the preliminary review, the 295-day review period promised by the MFDS must be met. Looking more closely at the reasons for the delays in the review period for new drugs, it can be assumed that there are still test items and data that only MFDS requires, and the preparation of these materials by supplementation was a factor in the delay. Since Korea became a member of the ICH, most of the guidelines have been internationally standardized, but there are still items that need to be improved, and this fee hike is the opportunity to harmonize the details of the review regulations internationally. With the development of the pharmaceutical industry and the advancement of new drug evaluations, the number and volume of review materials have increased dramatically, and the depth and complexity of the contents have reached a level that is incomparable to the past. So the reviewers of regulatory agencies who have to evaluate these materials are required to have the highest level of professional capabilities. Although the MFDS has been making great efforts to secure these talents, it has not been able to secure competent reviewers at the level of advanced regulatory organizations due to various constraints. Now that the new drug review fee has been raised to the level of advanced regulatory organizations, everyone is expecting that the MFDS will attract a large number of reviewers who own the best expertise. The increase in new drug reviews is expected to open a new era where various review innovations begin to be introduced. For the new system to take off and succeed, the MFDS, industry, and academia must continue to communicate, coordinate, and improve the system through open discussion. The MFDS has been working with many partners, including the industry, to become an advanced regulatory organization. I expect that the MFDS will continue to move forward step by step with its long-standing partners to become the world's leading regulatory agency, and I extend my warmest support to the MFDS as one of its former members and now one of its most enthusiastic supporters.
- InterView
- ‘Improve new drug access to treat rheumatoid arthritis'
- by Son, Hyung Min Nov 21, 2024 05:46am
- Dr.Sung Chul Shim, Professor of Rheumatology, Chungnam National University Hospital “Rheumatoid arthritis is not just a painful disease, but a disease that can cause direct damage to the joints. Patients need to start treatment with good treatments in a timely manner, but their access to new drugs is still limited. Switching between JAK inhibitors should be allowed freely so patients can receive personalized treatment.” Sung Chul Shim, Professor of Rheumatology at Chungnam National University Hospital, evaluated the current treatment landscape for rheumatoid arthritis as so during a recent interview with Dailypharm. Rheumatoid arthritis is a disease in which the synovial membrane becomes inflamed due to immune dysfunction. The disease initially starts with tingling and pain in the hands, but if left untreated, joint deformities can occur, accompanied by anemia, dryness, subcutaneous rheumatoid nodules, and pulmonary fibrosis. “People with rheumatoid arthritis don't realize that their joints are being damaged,” said Professor Shim. “They are often reluctant to start treatment early because they believe that taking pain medications is enough to relieve their symptoms.” “However, the molecules that cause pain are not the same molecules that are involved in joint damage. If you control the molecules that are involved in pain, such as prostaglandins, you can reduce the pain, but if you don't target the molecules that are involved in joint damage, your joints may continue to be damaged.” Professor Shim noted how rheumatoid arthritis has a poor early diagnosis rate. The golden time to treat rheumatoid arthritis is 2 years, and if treatment is not started within this period, joint deformity will begin, which is why early diagnosis and aggressive treatment are important. “The lack of early diagnosis in rheumatoid arthritis is due to low patient awareness,” said Professor Shim. If they recognize rheumatoid arthritis as a disease that destroys joints, they will start treatment sooner, but if they recognize it as just a painful disease, they will postpone treatment.” Multiple rheumatoid arthritis treatment options available...switching between drugs should be considered" The good news is that there are many treatment options available for the disease. From steroids to anti-rheumatic drugs to biologics to Janus kinase (JAK) inhibitors, there is a wide range of options available for prescriptions. “There are more treatments for rheumatoid arthritis than for any other disease, including oral and injectable medications,” says Dr. Shim, ”Yet as many as 10% of patients do not respond to the currently available treatment options. As such, having more treatment options doesn't necessarily mean they will work for everyone. Timely access to the right treatment requires an accurate diagnosis and a specialist who can switch medications at the right time for patients who have developed resistance. Currently, four JAK inhibitors are available, including Jyseleca, Xeljanz, Rinvoq, and Olumiant, but they cannot be switched between JAK inhibitors once started. Also, they cannot be switched to a biologic drug either. This is why the patients’ choices are limited despite the many treatment options available. In September, health authorities were expected to announce an amendment that allows switching between JAK inhibitors in rheumatoid arthritis but postponed it. The authorities are now expected to issue the amendment in December. “At this point, even with other therapies available for the same indications, we cannot use them,” said Professor Shim. There are patients who don't respond to one treatment, so we need to switch between drugs. There's no reason to keep them on the same drug when they're getting worse with it.” He added, “The goal of rheumatoid arthritis treatment should be to protect the joints, not control pain. For this, we need to be able to use the various treatment options available to us. It seems that governments are hesitant to allow switching because of the immediate budget impact. If the disease worsens and patients have to undergo surgery, this will be more costly in the long run.”
- Policy
- CKD drug Kerendia seeks indication expansion in KOR
- by Lee, Hye-Kyung Nov 21, 2024 05:46am
- Bayer Korea's Kerendia (finerenone), which is used to treat adult patients with chronic kidney disease with type 2 diabetes, will enter Phase III clinical trials in Korea to expand its indication. On the 20th, the Ministry of Food and Drug Safety (MFDS), approved a ‘randomized clinical trial to determine the efficacy and safety of finerenone on the morbidity and mortality of heart failure patients with left ventricular ejection fraction greater than 40% who were hospitalized for acute non-targeted heart failure episodes.’ Kerendia, which received domestic approval in May 2022, is indicated for the sustained reduction in estimated glomerular filtration rate (eGFR), progression to end-stage renal disease, and reduction in the risk of cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease with type 2 diabetes. Kerendia is a first-in-class, orally administered, selective, nonsteroidal mineralocorticoid receptor antagonist (MRA) that has a novel mechanism that inhibits kidney inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. In addition, Kerendia has recently been shown to prevent heart failure-related secondary events in HF with mildly reduced ejection fraction (HFmrEF) and HF with preserved ejection fraction (HFpEF) with a left ventricular ejection fraction (LV ejection fraction) of 40% or greater and has entered into global Phase III trials. The clinical trial to expand the indication to heart failure has also been approved in Korea. Meanwhile, results from the Phase III FINEARTS-HF trial, which evaluated Kerendia in heart failure patients with left ventricular ejection fraction greater than 40%, were presented at the European Society of Cardiology Annual Congress 2024 (ESC 2024) in September. Data from the Phase III FINEARTS-HF study showed that at a median follow-up of 32 months, there were a total of 1,083 worsening heart failure events in 624 of the 3003 patients in the Kerendia arm and a total of 1283 events in 719 of 2998 patients in the placebo arm. The total number of worsening heart failure events was 842 in the Kerendia arm and 1024 in the placebo arm, with an 18% lower incidence rate in the Kerendia arm. In addition, the proportion of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively, with a 7% lower hazard ratio observed in the Kerendia arm. However, there was no significant difference between death from cardiovascular events and all-cause mortality. According to drug research institution UBIST, prescriptions for Kerendia totaled KRW 1 billion in the first half of this year, and Bayer Korea is expected to expand the indications to further gain a competitive advantage.
- Company
- New CGRP antagonist 'eptinezumab' expected to be marketed
- by Eo, Yun-Ho Nov 21, 2024 05:46am
- Product photo of Lundbeck Yet another CGRP antagonist drug for migraine is expected to be marketed. Lundbeck's 'eptinezumab (Vyepti),' a CGRP antagonist for the preventive treatment of migraine, showed positive results in the global Phase 3 clinical trial in Asia involving Koreans. The drug is expected to enter South Korea quickly based on this result. Lundbeck has announced that in the Phase 3 pivotal SUNRISE trial, which was conducted to evaluate the efficacy and safety of the drug in patients with chronic migraines, eptinezumab met primary and all key secondary endpoints. Lundbeck's eptinezumab is an intravenous (IV) therapy used for preventive migraine treatment, sold in Europe and the United States. It was approved by the U.S. Food and Drug Administration (FDA) as a preventive migraine treatment in adults in February 2020. In January 2022, it received marketing authorization from the European Medicines Agency (EMA). Eptinezumab is being sold in over 30 markets worldwide in addition to the U.S. market. Ahead of its launch in Asia, Lundbeck achieved positive outcomes from the SUNRISE clinical trials. The SUNRISE clinical trial enrolled adult patients with chronic migraines who required preventive treatment. Symptoms of chronic migraine were defined as having a headache lasting more than 15 days in a month, with migraines occurring more than 8 days in a month. In a randomized, double-blind clinical trial, 983 patients were randomized and double-blinded to three treatment groups to receive eptinezumab 300 mg, 100 mg, or placebo by IV infusion. The effects were monitored for 12 weeks. The SUNRISE clinical trial results showed that eptinezumab significantly reduced monthly migraine days (MMD) compared to the placebo, meeting the primary endpoint. Measuring changes to MMD in chronic migraines during the 12-week treatment showed that the 300 mg-administered patient group had -7.5 days, the 100 mg-administered patient group had -7.2 days, whereas the placebo patient group had -4.8 days. Additionally, the eptinezumab 300 mg-or 100 mg-administered patient group had a significant MMD reduction of over 50% during the 12-week treatment compared to the placebo. In the SUNRISE clinical trial, the percentage of patients experiencing migraines the next after the eptinezumab infusion was significantly lower than the placebo, confirming that eptinezumab's preventive effects are experienced early. "In Asia, millions of people are affected by frequent and severe migraines, but only a few individuals use preventive therapy due to limitations of efficacy, safety, and drug tolerance," Johan Luthman, Executive Vice President in the R&D sector, stated. "We are very pleased with the SUNRISE clinical trial results. The current results will play a key role in Lundbeck's effort in providing eptinezumab to Asian patients who suffer from severe migraines," Luthman added. Meanwhile, Lundbeck plans to initiate the process of obtaining approval from the regulatory authority so that patients in Asia regions, including South Korea, China, and Japan, who suffer from migraines can readily use eptinezumab.
- Policy
- Strengthed regulations on human drug use in vet clinics
- by Lee, Jeong-Hwan Nov 20, 2024 06:08am
- A bill that requires frontline pharmacies to record detailed distribution details on human specialty drugs sold to veterinary hospitals has passed the Bill Review Subcommittee review. Although there was a lot of disagreement over the bill between the professions subject to the regulation - the pharmacists and the veterinarians - the Health and Welfare Committee’s Bill Review Subcommittee members agreed on the need to address the issue of misuse of human specialty drugs in veterinary hospitals. On the 19th, the 1st Bill Review Subcommittee of the National Assembly's Health and Welfare Committee reviewed and voted, and passed the bill to amend the Pharmaceutical Affairs Act, introduced by Representative Young-Seok Seo of the Democratic Party of Korea. The core of Seo's bill is to impose reporting obligations on pharmacists when they sell specialty drugs for human use to veterinarians at veterinary hospitals. The bill establishes a distribution management system that requires pharmacists to report their sales to the Korea Pharmaceutical Information Center every time they sell specialty drugs to veterinarians to prevent misuse and abuse of human drugs through veterinary hospitals. In addition, when pharmacists sell specialized drugs to veterinarians, they are required to submit the name of the veterinary hospital, contact information, drug name, quantity, and date of sale to the Korea Pharmaceutical Information Center in accordance with the Ministry of Welfare decree. If a pharmacist fails to submit the sales details or submits them falsely, he or she will be fined up to KRW 1 million. In particular, the bill mandates the computer network of the Korea Pharmaceutical Information Center to be linked to the veterinary prescription management system operated under the Veterinarians Act to transparently manage the distribution channels of specialty drugs sold to veterinarians. The Korean Pharmaceutical Association submitted a position in favor of the bill and the Korean Veterinary Medical Association submitted a position against the bill, but the Bill Review Subcommittee decided to pass the bill. Although the bill passed the Bill Review Subcommittee, it remains to be seen whether it can pass the Legislation and Judiciary Committee as the two professions are at odds. Earlier, Rep. Seo explained the background of the bill, saying that the process of selling specialized drugs for human use to veterinary clinics is causing issues of misuse and abuse, while at the same time, 'drug delivery,' which is prohibited by the current law, is also being carried out covertly.
- Product
- Gout drug allopurinol side effect alert
- by Kang, Shin-Kook Nov 20, 2024 06:08am
- As reports of adverse reactions to allopurinol, a drug prescribed for gout, continue to mount, health authorities are calling for genetic testing of patients before prescribing it to prevent side effects. According to medical and pharmaceutical associations on the 19th, the NMC Adverse Drug Reaction Committee recently reviewed applications for side effect damage relief of allopurinol-containing medicines and suggested the need for medical institutions to be informed of the ‘reimbursement of genetic testing before prescribing allopurinol.’ A notice regarding the reimbursement of genotyping fees before the first administration of allopurinol for all patients was issued in August 2021, but the committee believes the notice should be revised to request testing before prescribing. Allopurinol may cause a rare and potentially fatal Severe Cutaneous Adverse Drug Reaction (SCAR). Examples include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug hypersensitivity syndrome. As of 2023, allopurinol was the No. 1 drug (ingredient) causing adverse drug reactions in Korea, according to the Korea Institute of Drug Safety & Risk Management. The MFDS explained that “allopurinol-induced SCARs are highly associated with the HLA-B5801 allele,” and that Koreans have a higher rate of the gene than Westerners, allowing the prevention of adverse reactions through genetic testing. As a result, doctors and pharmacists should pay attention to follow-up, guidance, and medication guidance for allopurinol’s side effects.
- Company
- ‘Use of Prevenar 20 will rise to address the unmet need'
- by Son, Hyung Min Nov 20, 2024 06:08am
- Dr. Su-Eun Park, professor of pediatrics at Pusan National University Children Prevenar 20 has become the pneumococcal vaccine that covers the most serotypes in Korea. Experts believe that its use will increase to address the unmet need for a treatment that protects against serotypes not targeted by existing vaccines. Pfizer Korea held a press conference at the Lotte Hotel in Jung-gu, Seoul on the 19th to celebrate the approval of Prevenar 20 in South Korea. The Ministry of Food and Drug Safety approved Prevenar 20 as a new pneumococcal vaccine on March 31st. With the approval, Prevenar 20 is now available for ▲ the prevention of invasive disease, pneumonia and acute otitis media caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older; ▲ For the prevention of invasive disease and pneumonia caused by pneumococci (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) in persons 18 years of age and older. Prevenar 20 is Pfizer's first new pneumococcal vaccine in 14 years, which adds 7 serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) to the existing Prevenar 13 vaccine. In a clinical trial, the company confirmed Prevenar 20’s immunogenicity and tolerability against 20 serotypes in healthy infants after 4 doses. The results were also similar in another clinical trial that was conducted on adults. “Prevenar 20 demonstrated immunogenicity and safety against all 13 serotypes it shared with Prevenar 13, and 7 additional serotypes compared to the existing 13-valent pneumococcal polysaccharide vaccine,” said Dr. Sunju Kim, Medical Lead at Pfizer Korea. “More serotypes, more protection with Prevenar 20” Pneumococcus pneumoniae is an infectious disease caused by the bacterium Streptococcus pneumoniae, of which there are approximately 100 serotypes. In the United States, more than 150,000 adults are hospitalized for pneumococcal pneumonia each year. Streptococcus pneumoniae is the leading cause of bacterial pneumonia, meningitis, and sepsis in children worldwide. While the incidence of invasive pneumococcal disease is declining due to the availability of various vaccines, including Prevenar, the disease burden due to serotypes not covered by existing vaccines still remains. In a surveillance study on Korean pediatric invasive pneumococcal disease conducted from January 2014 to December 2019, frequent serotypes isolated from 168 cases included 10A (40 cases). 10A is one of the serotypes not targeted by existing vaccines. In addition, among the serotypes (67 strains) of invasive pneumococcal disease in children and adolescents in Korea that occurred between 2018 and July 2021, serotypes targeted by Prevenar 20 accounted for 54%. Dr. Su-Eun Park, professor of pediatrics at Pusan National University Children's Hospital, said, “The serotypes that were of an issue in Korean children have been added to Prevenar 20. It is expected to provide an additional 40% protection against pediatric invasive infection, 30% against otitis media, and 20% protection in adults.”
- Policy
- Stelara biosimilars face increasing competition
- by Lee, Tak-Sun Nov 20, 2024 06:08am
- Product photo of Janssen Competition among biosimilars referencing Stelara (ustekinumab) for treating autoimmune diseases heats up. Samsung Bioepis added its biosimilar to the reimbursement list in July, and Celltrion added theirs in September. Since Celltrion is set to cut the price starting next month, attention has been drawn to future competition. According to industry sources on November 19, Celltrion will cut the prices of existing products after their Steqeyma IV Inj, an intravenous formulation (IV), becomes listed for reimbursement in December. In September, Celltrion listed two Steqeyma PFS products for reimbursement, although the IV formulation was not included then. In contrast, the original Janssen Stelara and Samsung Bioepis Epyztek are available on the market with a total of three formulations, including the IV formulation. With the launch of Celltrion's IV formulation, the company has positioned well agaisnt the competitors. Additionally, by cutting its drug price, Celltrion has gained a competitive edge in pricing. The ceiling price for Steqeyma IV is KRW 1,278,313, making it more affordable than comparable formulations from Janssen and Samsung Bioepis. Janssen's Stelara S.C. Inj is priced at KRW 1,809,200, and Samsung Bioepis's Epyztek IV Inj is set at KRW 1,345,593. This makes Steqeyma approximately KRW 530,000 cheaper than the original product and about KRW 70,000 less expensive than the Samsung Bioepis formulation. Additionally, Celltrion has voluntarily reduced the price of its prefilled syringe formulation. Steqeyma PFS 45 mg price has been lowered from KRW 1,298,290 to KRW 1,233,376. For comparison, Janssen’s Stelara S.C. Inj·Stelara PFS are priced at KRW 1,745,600, while Samsung Bioepis’s Epyztek PFS is priced at KRW 1,298,290. This makes Celltrion’s product approximately KRW 510,000 cheaper than the original and about KRW 60,000 less expensive than Samsung Bioepis’ product. Additionally, the Steqeyma PFS 90 mg price has been reduced from KRW 1,342,320 to KRW 1,275,204. Currently, the original product is priced at KRW 1,804,800, and Samsung Bioepis' product is priced at KRW 1,342,320. Celltrion's prefilled syringe products were previously priced the same as Samsung Bioepis' products. However, Celltrion has officially entered the price competition with the recent price reduction. The price of the original Stelara will decrease to the KRW 1,500,000 range after its additional reimbursement ends in July next year. However, there will still be a significant gap compared to Celltrion's product, giving Celltrion an advantage in price competitiveness. According to IQVIA, Stelara's sales reached KRW 47.4 billion last year. It is reimbursed for treating moderate-to-severe plaque psoriasis in adults and children aged 12 and older, active psoriatic arthritis in adults, active Crohn's disease in adults, and moderate-to-severe ulcerative colitis in adults.
- Company
- Drug switching policy for atopic dermatitis fails to address
- by Whang, byung-woo Nov 20, 2024 06:08am
- A discussion has been advancing to allow drug switching between a biological agent and a JAK inhibitor for treating atopic dermatitis (hereafter referred to as atopy), and there have been further suggestions for the revision. The Health Insurance Review and Assessment Service (HIRA) has already established reimbursement criteria, but concerns have been raised about potential challenges in the effective use of the drug, including drug switching between drugs of the same class. (clockwise from top left) Product photos of Dupixent, Rinvoq, Olumiant, Adtralza, and Cibinqo The Embassy of Denmark in Korea met with the Severe Atopic Dermatitis Association (SADA) to discuss potential improvements to atopy treatment settings and systems. The HIRA has exchanged opinions with experts about allowing drug switching between a biological agent and a JAK inhibitor since September, and they have established the reimbursement criteria based on the latest documents and clinical practices. According to the pharmaceutical industry, pharmaceutical companies have submitted measures to voluntarily cut drug prices as part of financial allotment following expanded reimbursement. Attention has been drawn to whether it will pass the Drug Reimbursement Evaluation Committee (DREC) review, which is the final step during the appropriateness review process. However, the Severe Atopic Dermatitis Association (SADA) emphasizes that, while they have positive views towards the ongoing discussion about drug switching between treatments, an additional review of the revision to reimbursement criteria is necessary. Their chief suggestion for the draft of revision is recognizing the need for drug switching within the same class of drugs in addition to drug switching between different classes. Currently, drug switching for atopy is approved for drug switching between a biological agent and a JAK inhibitor. As a result, drug switching between drugs of the same class is not allowed. For instance, drug switching between biological agents such as Dupixent and Adtralza or JAK inhibitors such as Rinvoq and Cibinqo has been limited. However, drug switching between the same classes must also be considered considering many underlying mechanisms of atopy. In fact, SADA's '2024 Guidelines for the Treatment of Atopic Dermatitis in Korea,' which has been updated after 9 years, does not provide detailed recommendations for switching drugs between treatments due to the different properties of atopy. A SADA member said, "We do not have a set order of treatments because it is difficult to decide which drug is more suitable. The associations hope that drug switching becomes possible regardless of the classes." "Still limited drug switching between atopy treatments, we must consider all aspects" During the meeting with Daily Pharm, SADA President Joeun Park said, "Due to the nature of atopy, patients have different characteristics of atopy. When treatment options for drug switching are limited, patients may have difficulty in switching drugs." Park added, "Since the discussion about improvements to treatment setting is ongoing, in my opinion, there should be no limitations to the classes of drugs and the number." Currently, patients are more likely to choose drugs with the greatest market presence within the same class based on their experiences. Therefore, they may not significantly benefit from the treatment. In other words, Park is concerned that the current revision for atopy drug switching may not produce effective outcomes and could remain merely an administrative action. However, Park states that the government's draft for revision of six months for switching is sufficient. Park emphasized the need for the government to pay more attention to patients who are unable to receive JAK inhibitors. "In my opinion, patients typically do not respond to atopy treatment until around four months, with noticeable effects starting to appear around six months. Therefore, I support continuing treatment for up to six months," Park stated. "However, in a few cases, patients become pregnant while undergoing JAK inhibitor treatment. As a result, the government should implement more flexibility concerning these situations." (from left) Joachim Arup-Fischer, Commercial Counselor at the Embassy of Denmark in Korea, and Mads Friborg, Health & Medical Counselor at the Embassy of Denmark in Korea. & Medical Counselor at the Embassy of Denmark in Korea Regarding this issue, the Embassy of Denmark in Korea plans to collaborate on healthcare issues, including atopy. "In Denmark, the importance and influence of patient advocacy groups are growing. We are considering including this aspect in next year's business plan when collaborating with the Ministry of Health and Welfare (MOHW)," Mads Friborg, Health & Medical Counselor at the Embassy of Denmark in Korea, said. "We started to pay attention to atopy when HIRA's agenda was hotly debated. Additionally, we are considering discussing and bringing suggestions about the disease," Joachim Arup-Fischer, Commercial Counselor at the Embassy of Denmark in Korea, said. "Drug pricing was the chief discussion point during the recent meeting with the HIRA. From now on, we expect to discuss various aspects."
- Company
- Returned out-licensing, Daewoong's autoimmune disease drug
- by Son, Hyung Min Nov 19, 2024 06:13am
- Daewoong Pharmaceutical. Daewoong Pharmaceutical's new drug candidate, 'DWP213388,' for the treatment of autoimmune diseases is set to return after a year and a half. DWP213388, a new drug candidate developed as the First-in-Class, has entered the Phase 1 clinical trial. According to the Financial Supervisory Service (FSS) on November 16, Daewoong Pharmaceutical announced the U.S.-based biotech company Vitalli Bio has notified of out-licensing agreement termination for DWP213388, a treatment for autoimmune diseases. Both companies will undergo 60 days of negotiation and finalize the contract termination. Daewoong's upfront payment amounting to US$1.1 million is non-refundable. Daewoong Pharmaceutical had signed a global out-licensing agreement with Vitalli Bio, a subsidiary of the biotech investment firm, for its DWP213388 during the 'Korea-U.S. Digital and Bio-Health Business Forum' held on April 2023 in Boston, U.S. DWP213388 has a bispecific mechanism of inhibiting both Bruton's Tyrosine Kinase (BTK) and Interleukin-2-inducible T-cell Kinase (ITK), which are involved in activating immune cells such as B cells and T Cells. This new drug candidate received Phase 1 approval from the U.S. Food and Administration Agency (FDA) in 2022. In a preclinical trial, DWP213388 confirmed efficacy and safety in an autoimmune disease animal model. The Graft vs Host Disease (GvHD) mouse model study showed that DWP213388 effectively suppresses symptoms and improves survival rate. In a rheumatoid arthritis mouse model, DWP213388 demonstrated efficacy with a lower dosage than existing treatment and effects protecting bone damage. Additionally, an animal model study of cytomegalovirus (CMV) infections confirmed that DWP213388 effectively killed the virus. Most BTK inhibitors work selectively on B cells, suppressing BTK overexpression in B cells. The most prominent diseases caused by B-cell overexpression are blood cancers such as leukemia and lymphoma. DWP213388 also selectively targets ITK, another type of protein that regulates the immune function of T cells. BTK and ITK overexpression can result in the development of autoimmune diseases, including psoriasis, lupus, and inflammatory bowel disease. DWP213388 is different from existing BTK inhibitors in that it has high ITK-selectivity and low EGFR-selectivity, providing benefits of lower risk of side effects such as liver toxicity. BTK inhibitor may secure new indication…will it be a new opportunity for Daewoong? Daewoong Pharmaceutical's return of a new drug candidate is highly possible. Yet, attention is drawn to whether the company would obtain a new opportunity similar to the case of Hanmi Pharm. Hanmi Pharmaceutical had 'Poseltinib' returned from the global pharmaceutical company Eli Lily. However, Hanmi Pharm continues to develop the drug after changing indications. Poseltinib is a new drug candidate developed by Hanmi Pharm in 2010 for the first time, and it was out-licensed to Eli Lily in 2015. After that, Elily Lily failed Poseltinib's Phase 2 clinical trial for patients with autoimmune diseases and returned the development rights in 2019. After that, in collaboration with Korean bioventure NOBO Medicine (previously Genome Opinion), Hanmi Pharm discovered a new possibility of Poseltinib in diffuse large B-cell lymphoma (DLBCL) in a clinical trial. Both companies confirmed the safety and effectiveness of the combination therapy containing Poseltinib+Columvi+Revlimid. Based on the clinical results presented to date, of the 14 patients who can be assessed for response, the percentage of patients who met the objective response rate (ORR) recorded was 79%. Although it was early data, 36% of the patients reported complete response (CR) with a lack of all signs of cancer cells. No adverse reactions were reported in a cohort assessed for safety. In October 2021, Hanmi Pharmaceutical signed a joint development agreement with the Korean bioventure NOBO medicine for Poseltinib and jumped into the market for blood cancer treatments. Genome Opinion has been conducting an Investigator Initiated Trial (IIT) for triple-combination therapy containing Poseltinib, Roche's Columvi, and BMS' Revlimid for patients with relapse/refractory DLBCL at Seoul National Hospital.
