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- 2025-12-26 16:49:40
- Policy
- Background of reimbursement standards enhancement of Avodart
- by Lee, Hye-Kyung Nov 24, 2019 09:57pm
- Starting this month, the 5α-reductase inhibitors (5ARI), reimburesement standards of Pinagren tablets 5mg (Finasteride) and Avodart 0.5mg (Dutasteride), which are used to treat prostate enlargement and hair loss, will be strengthened. The Ministry of Health and Welfare has decided to reimbursement benefits when it is administered to 'positive prostate hyperplasia' among the permission of Pinagren and Avodart if both conditions are met. The conditions are as follows: ▲ more than 8 points of IPSS (International Prostate Symptom Score) ▲ Prostate size more than 30ml by ultrasound test or, if the rectal balance test showed moderate or more benign prostatic hyperplasia or serum seroprostate-specific antigen (PSA) levels exceeded 1.4ng/ml. In this regard, the Health Insurance Review and Assessment Service released a question and answer on the establishment of 5ARI reimbursement standards on the 5th and explained the background of strengthening the reimbursement standards of the two drugs. HIRA concluded that there is room to interfere with the correct interpretation of serum PSA level when serum PSA levels were decreased and used for early diagnosis of prostate cancer through taking 5ARI in the process of reviewing textbooks, clinical guidelines, and related opinions from the Korean Academy of Societies. The clinical literature also showed an increased probability of detecting high-risk prostate cancer in the 5ARI-treated patients, and HIRA said it has established a 5ARI reimbursement standards in consultation with relevant societies and associations to encourage the safe use of 5ARI. In addition, HIRA expected that problems such as decreased serum PSA levels and early diagnosis of prostate cancer related to 5ARI administration would be the same when administered for the purpose of treating male hair loss. HIRA explained that it is desirable to consult in a medical association or society considering that these male hair loss medicines are non reimbursement. The new reimbursement criterion 'must meet both conditions' means the condition at the start of 5ARI administration to benign prostatic hyperplasia. This condition was set in consideration of the clinical guidelines for benign prostatic hyperplasia published by a large group of experts (EAU, AUA, NICE, and Korean Urology Association). Excluded country guidelines suggest that the target of 5ARI administration are patients with a prostate size of 30-40ml or more. The related society suggested that 'more than 25-30 g of large prostate size' could be defined as 'more than moderate benign prostatic hyperplasia' There was also a description of the reimbursement condition that, during the administration of Pinagren and Avodart with both of the conditions, the PSA test should be performed at least once every 12 months to evaluate and record the value. HIRA said, "Because benign prostatic hyperplasia is common in men over 40 years old, When diagnosed with benign prostatic hyperplasia at this age, the experts’ opionion that regular assessment of the patient's condition through PSA testing is essential for early diagnosis of prostate cancer was reflected. However, the purpose of 5ARI treatment is to reduce prostate size and lower urinary tract symptom. Decreased serum PSA levels do not serve the purpose of treating benign prostatic hyperplasia, and sustained administration of 5ARI is possible even if PSA levels decrease during 5ARI administration. HIRA said, “In order to respect the autonomy of medical care, the inspection was made as a recommendation, not as a mandatory recommendation.” Patients who were diagnosed with benign prostatic hyperplasia prior to the establishment of the reimbursement standard and who received 5ARI may continue to receive the reimbursement even if they do not meet the two conditions. In the guidelines related to benign prostatic hyperplasia, Pinagren and Avodart are classified as 5ARI without classification according to the ingredients, and the same contents are mentioned. Both ingredients are considered reimbursement if they meet the conditions at the beginning of the administration under the reimbursement standard and alternative administration is possible.
- Policy
- IMD of Januvia approved, launching scheduled for Sep 2023
- by Lee, Tak-Sun Nov 22, 2019 06:32am
- The salt-modifying drug of Janivia (Sitagliptin Phosphate Hydrate, MSD Korea), which has a high share in the diabetes treatment market as a DPP-4 inhibitor was approved for the first time. This is Januritin alpha 100mg in Daewon pharmaceuticals. MFDS approved the marketing of Januritin alpha on the 19th as drug requiring the safety/efficacy review data submission. Januvia is a big drug with an outpatient prescription of ₩43.3 billion last year. In addition, Janumet, which combines Sitagliptin phosphate hydrate and Metformin hydrochloride, was the best out of diabetic medicine last year, with ₩ 69.4 billion in outpatient prescription sales. Of course, domestic latecomers are highly interested in entering the market. As a result of the development of late-release drugs, 149 cases of Sitagliptin drugs in domestic pharmaceutical companies were approved. The patent challenge also eliminated the patent for salts and hydrates in Januvia. At this time, 55 items that succeeded in patent challenge and first applied for permission obtained exclusivity for generics from Sep 2 2023 until June 1 2024, when the substance patent was terminated 'Januritin tablet 100mg', generic for Januvia and 'Januricombi', generic for Janumet in Daewon Pharmaceutical were also approved in Aug 2015, but did not obtain exclusivity for generics. However, with the initial approval of IMD, the company laid the foundation to enter the market even during the ban on exclusivity of generics. Januritin alpha in Daewon Pharmaceuticals is the first component of Sitagliptin hydrochloride in Korea. It is IMD(incrementally modified drug) synthesized from Januvia phosphate to hydrochloride. As long as there is no same ingredient, it is expected to be available for sale after Sept 2 2023, when the Zanubia material patent is terminated. Existing licensed products are 'Sitagliptin hydrochloride monohydrate with the same ingredients as Januvia or Sitagliptin hydrochloride '' without hydrates. A total of 55 items were approved for Sitagliptin hydrochloride. Attempts have been made to avoid material patents in Januvia. But in last September, patent tribunal dismissed the claim of a domestic pharmaceutical company. Domestic pharmaceutical companies tried to neutralize about 1 year extension to the substance patent as a salt-modified or hydrate-modified drug, but patent tribunal did not accept it. In last January, the Supreme Court ruled that the salt-changing drug also falls within the scope of the extended patent for substance. If the material patent challenge was successful, the launch of the late drug could be after July 5 2022. Currently, however, the patent is blocked, so the late-release drug of Januvia will have to wait another four years. It is the woe of a late comer.
- Policy
- NHIS collected 440 million won for valsartan indemnity
- by Lee, Hye-Kyung Nov 21, 2019 11:40pm
- Only 21.5 percent of pharmaceutical companies have paid the charged indemnity on valsartan damage. Report on ‘Valsartan related Indemnity Claim and Collection Status’ provided by National Health Insurance Service (NHIS) to Democratic Party Lawmaker Nam In-Soon stated the government agency has charged 69 pharmaceutical companies 2.03 billion won as indemnity for additional National Health Insurance expenditure made. However, only 26 out of 69 of them, or 21.5 percent, have paid 436 million won to the government. NHIS announced it spent about 2.03 billion won the agency was not liable for, due to the drug exchange order on already dispensed valsartan medicines last year. The amount consists of 964 million won for diagnosing 109,967 patients, and 1.07 billion won for dispensing other option of treatment to 133,947 patients. Accordingly, the agency charged indemnity for the additional expenditure against 69 pharmaceutical companies on Sept. 25. The first payment deadline was on Oct. 10, but the initial collection rate reached about 4.8 percent. After the second deadline on Oct. 31, total of 26 pharmaceutical companies paid 21.5 percent of the charged indemnity. “Based on external legal consulting, pharmaceutical manufacturers had a fault in safety of manufactured products. On the grounds of product defect as stated in the Product Liability Act, the government claiming for damages was confirmed legitimate. The agency is considering on filing a litigation case worth 1.59 billion won against 43 companies for the unpaid indemnity payment”, NHIS official explained. Meanwhile, pharmaceutical companies with the unpaid due are reportedly considering on taking a joint legal action or litigation to prove absence of legal liability, when NHIS files for damage suit.
- Policy
- Dupixent, reimbursement in next January upon settlement
- by Lee, Hye-Kyung Nov 20, 2019 06:33am
- Treatment for severe atopic dermatitis, Dupixent are under drug price negociations. NHIS(National Health Insurance Services) recently released this fact on its website. NHIS concluded pre-negotiation with Sanofia aventis before entering into drug price negotiations. Drug negotiations will last up to 60 days. If the drug price negotiations between the NHIS and pharmaceutical companies proceed smoothly, the reimbursement is expected to be secured in next January. Dupixent passed the HIRA's Pharmaceutical Evaluation Committee on October 11th. After negotiating a drug price agreement with the HIRA, it is necessary to put a name on the final list of reimbursement after deliberation by the MOHW Insurance Policy Review Committee. Dupixent will follow the RSA process as a treatment for serious diseases through ‘the detailed evaluation criteria of new drugs’ in August. Once the price negotiations are concluded, they will be the first beneficiaries of the expansion of RSA. The existing RSA system was only applicable to drugs for cancer and rare patients. However, due to its high price, Dupixent was also a target of RSA in that there were some broken cases when there is too much finance.
- Policy
- All prescription drugs to hand in bioequivalence test result
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies. Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its plan to enact partially revised ‘Regulation on Pharmaceutical Safety’, as a follow-up to the excessive commercialization of generics and last year’s valsartan incident with carcinogen contamination. The ministry is to accept public opinion on the matter until Jan. 20, 2020. For Korean pharmaceutical industry that bases most of business off of generic products, the revised regulation is the most detrimental level of regulation to hinder the industry. Some of regulations were previously alleviated on a moderate level, but they are now tightened back again. ◆ Bioequivalence test for all prescription drugs: First, all prescription drugs are to be gradually obligated to hand in bioequivalence test data. Currently only prescribed tablet, capsule, suppository and other specific drugs designated to provide bioequivalence test result were required to submit the material. About 60 percent of prescription drugs are included in the said subject group. But from now on, the applicable drug regimen types would expand out to all kinds. The administration method types required to provide bioequivalence test material would expand on oral in 2020, aseptic techniques including injection in 2021, and all the other types in 2022. Based on its cost-benefit analysis, MFDS projects affected pharmaceutical companies would spend about 164.4 billion won according to the revised regulation. The analysis estimated a single case of bioequivalence test would cost about 220 million won. ◆ Specification submission exemption removed: All prescription drugs would be obligated to hand in specification material. Specification, containing pharmaceutical test procedures and acceptance criteria for new drug, is to provide information on the drug’s manufacturing and test methodology and criteria for quality control, which also includes evidence and test performance data. Except for biopharmaceuticals, currently a drug listed on an official compendium, such as Korean Pharmacopoeia, was exempted from the material submission. Some officially recognized compendium include Korean Pharmacopoeia, Korean Herbal Pharmacopoeia, Good Manufacturing Practice criteria, and other official compendium or pharmacopoeia acknowledged by Minister of Food and Drug Safety (i.e. U.S. Pharmacopeia, Japanese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, German Pharmacopoeia, and French Pharmacopoeia). However, there would be no exception from now on. As of 2017, 51 percent of prescription drugs applying for approval were listed on the official compendium. MFDS suspects additional cost would be spent on evaluation service fee, as companies would already have documented specification related materials. The industry is expected to spend about 3.2 billion won, due to the revised regulation. ◆ CMOs to hand in GMP evaluation results: Besides the bioequivalence test, MFDS is also requiring contract manufacturing organizations (CMOs) to submit GMP status report and evaluation results. At the moment, the submission is exempted for drugs wholly manufactured in contracted manufacturer. GMP status report and evaluation result should include manufacturing plant floor plan, plant facility and environment management information, GMP-dedicated organization chart and related documentation rules, product specification related to applicant item, record of product and quality control, and copy of validation result. MFDS analyzed that annually 738 items are manufactured by CMOs. The ministry deduced the average number based on approved CMO products from 2012 to 2017, assuming items sharing joint bioequivalence test result are entirely manufactured in external facility. The health authority estimated the revised regulation would have companies to spend about total of 3.7 billion won. MFDS also clarified no additional documentation on GMP evaluation is required other than the materials filed by the client company, but explained additional cost would be probably spent on human resources and evaluation service fee.
- Policy
- Consigned items duty to produce on the rise, Overregulation
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- As the MFDA foretells the resurgence of mandatory production of three batches of consignment items as a solution to the problem of generic stagnation, the pharmaceutical industry is pushing for excessive regulation. It is dissatisfied that consignment production is bound to be stopped if mandatory production of consignment items is obligated while abolishing consignment. The MFDA included these details when it announced legislation on the revision of some of the rules on safety of medicines and others. In addition, it is necessary to submit data on the evaluation of the GMP implementation status in the future manufacturing process. The GMP implementation assessment data also includes validation data to verify the uniformity of the product. Validation data is pre-checked through three batch productions. In other words, a drug produced at another plant will have to produce three batches of data from the plant when approved. Depending on the manufacturing facilities, as many as 100,000 tablets are produced per batch. When placed three times, 300,000 tablets are made. Pharmaceutical companies will not lose money if they sell 300,000 tablets produced for permits. In addition, submission of GMP data will also lengthen the license period. This is a big burden for the consignment company. Of course, trustees can benefit from additional production. However, most pharmaceutical companies are expected to suffer damage in the midst of active consignment production. In addition, the MFDA's stance is to phase out the allowance for joint and consigned living. The MFDA announced in a regulation notice that, starting from next June, the number of items allowed for joint and entrusted livelihood will be limited to three companies, and not allowed from June 2023. In addition, the MFDA is in a position to lower drug prices for consignment and joint livestock products. In the meantime, if consigned drugs are reinstated to become mandatory to produce three batches, the counterfeiting transaction between pharmaceutical companies will be markedly reduced. The provision of mandatory production data for three batches of consignment manufacturing items disappeared following the introduction of the 2014 GMP Conformity Decision. The revival will bring back regulation in almost five years An official in the pharmaceutical industry said, "In the event of last year's Valsartan, there was an opinion that we would revive the production of three batches of consignment items without leaving the co-provisioning regulations." The MFDA announced the revision of the rules on safety, such as the drugs, as well as mandating the production of three batches of consigned drugs, and expanding the subjects for submitting biotest data to all specialty drugs, and eliminating the exemptions for submitting the law. In addition, it will revise the report on overseas safety measures related to the suspension or withdrawal within from 15 days to 3 days, and the burden on pharmaceutical companies is expected to increase further.
- Policy
- Annual sales↑to ₩6.5 billion by generic exclusivity
- by Lee, Tak-Sun Nov 20, 2019 06:32am
- Myung-jin Chung, director of KHIDI, is announcing the results of the impact assessment on the patent linkage According to a survey result, the drug costs in 2018 were reduced by up to ₩4.8 billion due to generic drug exclusivity. Sales of generic pharmaceutical companies increased by up to ₩6.5 billion while the original company's drug costs were reduced by ₩11.3 billion. Myung-jin Chung, general manager of KHIDI, announced the results of the four-year impact assessment of the Patent linkage at the '2019 Drug Licensing Patent Linked System Policy Forum' held at the Four Points Hotel, Seoul Guro on the 19th. The impact assessment of the patent linkage began in 2016 under the applicable Act and was the fourth time this year. The study period was from April to October of this year, and the study was conducted on drugs that received prohibition of sale or generic exclusivity from January 2018 to December 2018, and their disposal were terminated (expiration of the period, expiration of effect, etc.). During this period, there were 29 items in generic exclusivity, and the targeted brand listed drugs were 5 items. The representative generic exclusivity drugs include 10 generic products of the osteoarthritis named “Layla” and 14 generic products of the hepatitis B named “Viread”. As a result, early entry effect of late drug market was 1.3 ~ 4.6 months. Early entry effect was based on 9 months from the date of notification to the original company following the application for the permission of generic exclusivity. If the original company asks for a prohibition of sale under the patent linkage system, it will not be able to enter the market for 9 months. The sales of generic companies, which acquired the generic exclusivity, increased from ₩5.696 billion to ₩6.473 billion. On the other hand, targeted pharmaceutical companies with the original listed drugs declined from a minimum of ₩9.9 billion to sales of ₩11.3 billion. In the case of Viread, pharmaceutical companies with listed drugs declined from ₩6.2 billion to ₩7.6 billion. On the other hand, Generics sales increase from ₩3.4 billion to ₩4.2 billion. As a result, the drug costs have been reduced from ₩4.53 billion to ₩4.76 billion. The indirect effect of generic exclusivity items is an increase in the research development costs and employment. According to the research results, the R & D expenditure increased from minimum of ₩180 million to maximum of ₩360 million. Employment also increased from a minimum of 19 people to a maximum of 38 people. Myung-Jin Chung said, "Prior to the 4th year after the implementation of the system, the approval of generic exclusivity has had a positive effect on the domestic pharmaceutical industry and health policy." He added. “Unlike concerns when introducing the system, original companies don't apply the prohibition of sale much. Activation of the genetic exclusivity has led to a rise in sales of domestic pharmaceutical companies.
- Policy
- Champix patent expires soon, follow-ons eager to launch
- by Lee, Tak-Sun Nov 18, 2019 10:21pm
- Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original. Seemingly, Yuhan is preparing for the Pfizer’s Champix’s patent to expire in next July. On Nov. 11, Ministry of Food and Drug Safety (MFDS) approved an investigational new drug application for Phase 1 clinical trial on Yuhan’s candidate medicine, ‘YHP190’. The study protocol states it aims to compare and evaluate pharmacokinetics of healthy adult subject arms taking 1mg of YHP1903 and 1mg of Champix tablet, respectively. The commercial clinical trial is to be initiated for the regulators to approve Champix’s follow-on medicine. Yuhan’s development of Champix’s follow-on drug and its clinical trial has gotten the industry’s attention as the company is currently co-promoting the original Champix with Pfizer Korea. In September last year, Yuhan signed a joint sales deal with Pfizer Korea. It was a co-promotion strategy to defend Champix’s market share from incrementally modified drug (IMD) launching in November same year. The IMD with a change in saline substance of Champix was able to enter the Korean market as it evaded extended term of the original’s substance patent. The Intellectual Property Trial and Appeal Board ruled the IMD does not infringe the original’s patent with extended term. However, the table turned in last January, as the Supreme Court on other case ruled that an IMD with changed saline substance does not evade extended patent. The Champix’s IMD released in November last year stopped most of its manufacturing after January. Korean court is expected to hand down the ruling on Champix’s IMD on coming Dec. 20. On the other hand, MFDS has already approved of 72 IMDs related to Champix. But initially Yuhan did not submit a follow-on drug approval application, due to its joint sales deal. Although the sales of IMDs are blocked at the moment, it would resume from July next year when the extended patent term expires on July 19, 2020. There are saline substance and composition variant patents expiring on Jan. 31, 2023, but most of Korean companies are evading the patent as they are using different substances. At last, July next year would be the long-awaited start of the heated smoking-cessation medication market competition. While many companies are eager to launch items in same class, the pharmaceutical industry is keeping a close eye on Yuhan with co-promotion deal over the original, to see if it would also join the follow-on drug market competition. Meanwhile, IQVIA reported Champix sales in the first half of the year plummeted by 51.1 percent, compared to same time last year, and that the drug only generated 11.5 billion won. The sudden drop of sales was affected by the original’s price reduction due to release of IMDs and decreased number of participants applying for government-supported quit-smoking program.
- Policy
- 5 or more medications were taken by 68% for older people
- by Kim, Jung-Ju Nov 18, 2019 05:34pm
- Korean proportion of 75 years and over who are taking more than 5 medications concurrently exceeded 68%. It is far exceeding the average of 48% of OECD –member countries. Diabetic prescription rate of first choice antihypertensive medication patientsis 78%, which is lower than the average of 83% in OECD-member countries, but is steadily increasing. In particular, more than eight out of 10 patients said they had enough consulation hours. MOHW(Ministry of Health and Welfare) announced on Nov 17th analyzing the level and status of Korea and each country based on the 2017 results of health care presented by the OECD. In Korea, ▲ the quality of acute care and outpatient care is continuously improving. ▲ In particular, the level of colorectal cancer and gastric cancer is the highest level among OECD countries. ▲ The level of outpatient prescription is gradually improved, but management by the multi combination prescriptions is required. The multi combination prescriptions means administration of five or more drugs with different ingredients for more than 90 days. Acute myocardial infarction and stroke 30 days mortality after admission to hospital ◆Acute care= Acute myocardial infarction and stroke 30 days mortality rate are representative indicators of the quality of the acute care area. within 30 days of acute stage patients over 45 years of age. The 30-day mortality rate for patients hospitalized for ischemic stroke (over 45 years) in 2017 was 3.2%, the superior level among OECD countries. The OECD average is 7.7%. The 30-day mortality rate for acute myocardial infarction has declined since 2008, but has increased since 2016, with 9.6% in 2017, higher than the OECD average. The OECD average is 6.9%. Cancer five year net survival ◆Chronic disease = Among the chronic diseases that are managed well in primary care areas, hospitalization rates for asthma and diabetes were 81 patients per 100,000 people and 245.2 patients per 100,000 people, respectively, higher than the OECD average. The OECD average is 41.9 patients per 100,000 people for asthma and 129 patients for diabetes. Chronic disease admission rates have only declined since 2008, and COPD disease admission rates are approaching the OECD average ◆Cancer care = The five-year net survival rate in Korea is the highest level of cancer care, with colorectal cancer of 71.8%, rectal cancer of 71.1% and gastric cancer of 68.9% Five-year net survival means the cumulative probability that a cancer patient will survive five years after diagnosis if cancer is the only cause of death. The 5-year net survival rate of lung cancer patients (25.1%) was higher than that of OECD countries (17.2%), and acute lymphocytic leukemia was 84.4%, slightly higher than the OECD average (83.7%). ◆ Outpatient prescription = Outpatient prescription level is determined by ▲ multidrug prescription ▲ opioid prescription ▲ antipsychotic prescription ▲ antibiotic prescription rate ▲ diabetes patient prescription ▲ benzodiazepines prescription. Data on multidrug, opioid and antipsychotic prescriptions were first collected this year. First, a multi-drug Prescription is defined as the proportion of patients 75 years of age or older who are chronically taking five or more drugs. In 2017, Korea accounted for 68.1%, the highest among the seven countries that submitted statistics (average: 48.3%). The total prescription for opioids, a narcotic analgesic, was 0.9DDD / 1000 people per day, the lowest next to Turkey. In Korea, narcotics prescriptions are low due to strict narcotics regulation and control , and repulsion from the term of “narcotics”. Defined Daily Dose (DDD) is the average dose that must be taken throughout the day for the main ingredients of the drug to take effect. The prescription rate for antipsychotics for patients 65 years of age and older is 36.2 per 1000 prescription populations, which is among the lowest in the 16 countries where statistics were submitted. Hospital admission rate In 2017, the amount of antibiotics for outpatient’s prescriptions in Korea was 26.5DDD / 1000 persons / day Medication prescription adequacy in diabetics is measured by first-choice antihypertensive * and hypolipidemic ** prescription rates. Primary antihypertensive agents are drugs used in the initial treatment of hypertension and include diuretics, beta blockers and alpha beta blockers, calcium antagonists, angiotensin converting enzyme inhibitors (ACE inhibitors), and angiotensin receptor blockers (ARBs). Lipid lowering agents are drugs that control blood lipids, such as cholesterol. For diabetics, higher prescription rates produce better results. Prescription rate to reduce the risk of diabetic nephropathy and to slow the progression of hyperalbuminemia in patients with diabetes with high blood pressure is 78%, which is lower than the OECD average (82.9%), but is increasing. In order to prevent cardiovascular disease in diabetic patients, the medical guidelines * recommend prescribing lipid-lowering drugs.In Korea, the level of drug prescription ** in diabetics increased by 23.3% p from 44.1% in 2011 to 67.4% in 2017. Hypnotic benzodiazepines are drugs that require caution due to the increased risk of side effects such as cognitive impairment and falls when taken over 65 years. The long-term prescribing of benzodiazepines was 10.1 patients per 1000 population over the age of 65, lower than the OECD average (33.9). Among the benzodiazepines, long-acting drugs were prescribed for 146.3 patients per 1000 people over the age of 65, more than the OECD average of 52 (52), but significantly lower than in 2011 (241.5). Long-term action of benzodiazepine drugs is expected to have a longer half-life when taken by the elderly, resulting in negative effects due to excessive sedation. Prescribing in primary care related patient safety Prescription and mental health related to patient safety = 80.8% of patients reported that their doctors had enough time to check out their consultation based on the 2018 medical service experience survey. In addition, 82.9% and 82.4% of the respondents explained that the doctor explained it in an easy-to-understand manner and participated in the decision-making process. The excess mortality rate for schizophrenia was 4.42 and 4.21 for bipolar affective disorder, higher than the OECD average (4, 2.9, respectively).
- Policy
- VMS treating fezolinetant Phase 3 approved in Korea
- by Lee, Tak-Sun Nov 18, 2019 06:23am
- An investigational medicine treating vasomotor symptoms (VMS) associated with menopause is to conduct a Phase 3 clinical trial in Korea. On Nov. 15, Ministry of Food and Drug Safe approved of Investigational New Drug (IND) application of fezolinetant for transnational Phase 3 clinical trial taking place in Korea. Acquired by a Japanese pharmaceutical company Astellas in 2017, a Belgium-based pharmaceutical company Ogeda SA has been developing the fezolinetant pipeline. The approved trial is to investigate efficacy and safety of fezolinetant on Asian women struggling with moderate-to-severe menopause-related VMS like hot flashes. Fezolinetant, an oral selective neurokinin-3 (NK3) receptor antagonist, is an emerging non-hormonal option for managing VMS. Reportedly, more than a half of women around the world in menopause experience VMS. The most prevalent symptoms are hot flush, heart palpitation, night sweating, anxiety and depression. To this day, estrogen-like hormone therapy was recommended the most. But hormone therapy should be taken with a caution as it could cause risk of breast cancer and other adverse reaction. The Phase 2 trial of fezolinetant reported significant reduction of the VMS frequency, specifically for hot flush, compared to a placebo group. The trial did not have any apparent adverse reaction reported. Having a high expectation on the innovativeness of fezolinetant, Astellas acquired Ogeda SA with a paycheck of EUR 800 million (about 1.29 trillion won). As soon as the non-hormonal VMS compound completes its late stage clinical trial in Korea successfully, it would initiate regulator’s approval procedure.
