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- [Contribution] On MFDS’s new drug approval fee hike
- by Whang, byung-woo Nov 21, 2024 05:46am
- 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.&160; 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 &8211; 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 &8211; 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.&160; 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.&160; 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.&160; 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.&160; 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.&160; 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.&160; 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.&160; 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
- “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.”&160; 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.”&160; 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.&160; 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.&160; “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.
- 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&160;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&160;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&160;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&160;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.
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