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- 2026-05-09 19:26:49
- Policy
- Investigation of raw materials for Metformin in Singapore
- by Kim, Jin-Gu Dec 09, 2019 06:27am
- The three Metformin products recovered from Singapore have yet to be imported in Korea. The Singapore Ministry of Health (HSA) recently surveyed 46 locally Metformin products and recovered three of them. N-nitrosodimethylamine (NDMA) was detected above the daily allowance (96 nanograms), explains the HSA. Two controversial companies are Glorious Dexa and harmazen Medical Pte Ltd. Recovery targets are Glorious’ Glucient XR Tablet 500mg and Pharmazen's Meijumet Prolonged Release Tablet 750mg and 1000mg. In the case of Pharmazen Medical Pte Ltd, the products produced in all batches are subject to recovery. However, the Singapore Ministry of Health does not specifically explain the level or cause of detection. NDMA detection Metformin products released by the Ministry of Health of Singapore. It is confirmed that there are no imports of this drug in Korea NDMA detection Metformin products released by the Ministry of Health of Singapore. It is confirmed that there are no imports of this drug in Korea At present, there is no record of domestic imports of such drugs as confirmed by the Ministry of Food and Drug Safety. However, the drug substance of the finished drug is not confirmed. In other words, the possibility of domestic products using the same drug substance is not completely excluded. An official from the Food and Drug Administration said, “If the drug has imported in Korea, it is required to register the drug, but all three items have not been imported and ewe should contact Singapore directly, the drug substance company should be identified as early as Monday”. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) today announced that they will begin an NDMA test for Metformin preparations on Monday (local time). The direct reason is Singapore’s issue. The Singapore Health Department announced the recovery of three Metformin items four days earlier.
- Policy
- Introduction-development-turn, and the price reduction
- by Kim, Jung-Ju Dec 06, 2019 09:46am
- The pharmaceutical industry's reaction to the ambitious post-evaluation of the high-priced drugs, ambitiously issued by the government and insurance authorities, is cold. The pharmaceutical community understood the big direction of follow-up of drugs for rational fiscal expenditure, coupled with enhanced security. At the same time, it is a matter of responding to various drugs and drug prices that are popping up around the market in a way that reduces prices At the site of ‘the Public Hearing for Establishment of Post-Drug Evaluation Criteria and Methods’ held by the HIRA on the 3rd, the officials of the pharmaceutical industry censure in the plan proposed by the HIRA and the MOHW. Pharmaceutical officials who came to the public hearing did not leave after the event and contacted the insurer. The biggest problem for the pharmaceutical industry is that the re-evaluation of effectiveness (clinical utility) planned by the HIRA is a repetition of the registered contract list maintenance project from 2007 to 2011. This is a problem of overlapping hurdles, namely safety effectiveness. For governments and insurers, the market entry for licensed items and the positive gateway for payroll entry are distinctly different, but this also leads to overlapping regulations in the industry of developing and selling drugs to patients. An official of a large pharmaceutical company who attended the audience complained of fatigue, saying, “I agree with the purpose of the reevaluation, but I don't understand the results and performance of the 2011 reimbursement item’s list, and am feeling of overlapping with the application of the business at that time”. The official also said, "If the MFDS reevaluates and revokes the revoked or revised permit, anyone can agree, but we have no choice but to argue against it." There was a continuation of the question of whether the government could cover the value of drugs with a revaluation to be introduced. Another official said, “If there is no difference from the evaluation made during the MFDS approval process, and if the level of clinical literature quality evaluation is uplifted, will separate the wheat from the chaff?” “We are qualitatively evaluating the effectiveness passed by the MFDS on a document-based basis. If we don't meet the criteria, we can be perceived as an ineffective drug”. This post-evaluation also voiced the need for a social consensus whether or not the policy was appropriate for the principle of insurance in terms of the so-called 'trade off', which the government explained earlier this year. An official of the pharmaceutical industry said, “Our country is already managing the drug price in the screening system. We have already passed the validity of MFDS before entering the reimbursement”. Eun-young Park, head of the Drug Management Division, in charge of improving the evaluation of the MFDS, said, “The reevaluation of MFDS is the least effective for safety, and what we see is the framework of randomized clinical trials.” "We've improved our standards, and we want to create a clinically useful environment for how cost-effective it is to patients on the reimbursement list after screening." The industry's doubts have not eased despite clarifications that pharmaceutical companies intend not to deny the safety efficacy of drugs that they have been working hard on, but rather to see their value and adequacy. Even after the public hearing, pharmaceutical workers were seen talking about the policy in the lobby. Concerns have also been raised about foreign policy prices. It is because the evaluation criteria can be completely changed according to the will of the government, and there are also controversies and risks about how to set the comparison method and the index. The Korea Pharmaceutical Bio Association said, "It is only a reference because the government and academia are not able to confirm the actual selling price of foreign countries when talking about the new drug price controversy." "Comparing prices in eight countries" is an unreasonable attempt. " KRPIA also criticized the government's direction to lower the price of medicines to solve various issues surrounding pharmaceuticals. An official of KRPIA stressed that “the factors that determine finances are price and usage, we should ignore the focus on usage and avoid the direction that leads to drug price-oriented policies”.
- Policy
- Investing KRW 4 tn fostering Biohealth as ‘Post-semiconduct
- by Kang, Shin-Kook Dec 06, 2019 09:43am
- Until 2025, the Korean government is to assertively invest four trillion won on fostering biohealth industry as a ‘post-semiconductor industry.’ On Dec. 4, Deputy Prime Minister Hong Nam-ki led the fifth Innovative Growth Strategy meeting and the 28th Economic Ministerial meeting and discussed about next generation innovative growth engine, related validation process and additional plans. First, the government has decided to concentrate the state capability on developing biohealth industry, because new drug export volume was tripled from 1.4 trillion won in 2017 to 4.4 trillion in 2018, expanding the foundation of technology. Deputy Prime Minister Hong Nam-ki presiding at Innovative Growth Strategy meeting (middle) The government aims to grow biohealth industry as a next generation economic growth engine, or so-called ‘post-semiconductor industry’, by investing four trillion won on R&D until 2025 and developing and emerging technology. The government’s plans are to set a roadmap for biohealth regulation reform within this month to implement it from next year, and to establish human resources development center for biotechnology training two thousand experts at a time. Moreover, the government is also working on innovation strategy and plan for the service industry. The plan is to expand total service industry based on three major types of Manufacturing as a Service (MaaS), Healthcare as a Service (HaaS), and Financial Accounting Advisory Service (FAAS). MaaS is to be expanded centering a voucher program supporting companies in need of manufacturing service, whereas HaaS would develop pilot programs and validate and expand it in different regions. FAAS is to open encrypted big data of credit information provided by Korea Credit Information Services. However, the government officials expressed regret as the key regulatory reform plans for remote medicine, sharing economy and more are surrounded by fierce dispute between stakeholders and social conflicts. Specifically, the officials pointed sluggish process of revision of the three data protection laws essential for the growth of emerging industry, and that it is limiting the industries’ performance. The three information protection laws are; Personal Information Protection Act; Act on the Protection of Information and Communications Infrastructures; and Credit Information Use and Protection Act. Deputy Prime Minister stated “The government plans to foster biohealth as the next generation economic growth engine following the footsteps of semiconductor, and also it would set state-led artificial intelligence strategy, create data economy, and activate startup ecosystem for all product cycle.” “The Economic Policy Plan 2020 would contain policy focus and goals immediately in effect from next year and it would be presented to the public all together by the end of the month. To propel the innovative growth in stable and effective fashion, refining legal and regulatory foundation with legislation would be crucial,” the Deputy Prime Minister added.
- Policy
- “Providing as much clinical information for patients”
- by Lee, Tak-Sun Dec 05, 2019 06:23am
- Director Kim Jeong-mi of Clinical Trial Management Division Since the end of last October, the Korean Ministry of Food and Drug Safety (MFDS) has expanded scope of information on approved investigation new drug’s (IND) protocol uploaded on its website. Previously, only the names of clinical trial, sponsoring client, IND, targeting disease and clinical trial institute were publicly disclosed, but now more information, including comparison drug, contact information of the institute, subject selection and exemption standards are also uploaded online. Anyone can now check a company’s R&D progress in detail on the website, and patients can search information and actively participate in a clinical trial by contacting the clinical institute directly. At a press conference held on Dec. 3, Director Kim Jeong-mi of Clinical Trial Management Division at MFDS explained, “Although clinical trial information has been disclosed since 2007, we’ve been thinking that we are not meeting the patients’ expectation. We recognized the need to publicly provide similar level of information as other countries, so we formed a consultative body for clinical trial system development to specify expansion of the provided information.” “Our principle is to disclose as much information as the U.S. or EU. But the update has been slow as double-checking accurate information is taking more time than we expected,” Director Kim added. Expanding provided scope of clinical protocol information is expected to support patient’s right to know and their active participation in clinical trials. Revealing contact information of the healthcare institute was to meet the existing demands of patients seeking opportunities to participate. “These days, patients have gotten sophisticated so much to actively look for related information and to get highly knowledgeable in particular medicines. Naturally, they are curious about contact information of clinical institute and doctors in charge. Some are even eager to transfer the hospitals to participate in clinical studies”, Director Kim elaborated. Disclosed clinical protocol information has been expanded partially, but the website still lacks in system stability and promotion. Particularly because MFDS’ Drug Information System website (www.nedrug.mfds.go.kr) provides a vast amount of information on drugs, searching for IND approval status on the website takes a long time. Moreover, many people still do not realize the website provides IND information. The director said, “We still need to contemplate on how to provide the information with easier access. Also we are considering on making information search easier for IND developers and researchers.” In August, MFDS announced the Five-year Master Plan on Developing Clinical Trial System. The five-year plan aims to strengthen safety control over clinical trials and enhancing international competitiveness. Director Kim commented, “We have had a lot to ponder as transnational clinical trials have been stagnating recently and we want to create an advanced clinical environment and protocol review system in Korea attractive enough for Korean companies to develop global IND. The five-year plan has details of strengthening safety management and international competitiveness, communicating better of clinical trials and shifting public’s bias.” One of the highlights of the plan was making drug safety update report (DSUR) mandatory. The director explained, “Unlike late-phase clinical trials, earlier-stage trials have more prevalent risk of safety issue and adverse reaction. And to promote the earlier stages of trials, the ministry plans to tighten evaluation on trial sponsor and safety control on trial conductor. DSUR has been filed by multinational pharmaceutical companies, but we are also asking Korean companies to file them with the amendments.” Review on early phase clinical trials would be strengthened as well. By forming Innovative Early-phase Clinical Trial Review Team, MFDS plans to conduct overall review not only for INDs, but also on pharmacology test, quality, and statistics. “Without removing negative bias on clinical trials, Korea would struggle to acquire clinical competitiveness. We are planning to extend communication channel and to raise better awareness of clinical trials by working closely with Korea National Enterprise for Clinical Trials (KONECT) and consultative body for clinical protocol review,” Director Kim said. Nevertheless, the director stressed, “In other countries, clinical trial participation is considered as a ‘volunteer service’ with a side of treatment opportunity. But in Korea, clinical trials are regarded negatively rather than necessary. When the majority of the public can agree clinical trial is essential to the society, the need of new drug development and industrial benefit of drug development could be emphasized.”
- Policy
- Forxiga, solvate modifier applied for the first permit
- by Lee, Tak-Sun Dec 05, 2019 06:22am
- Diabetes treatment, Forxiga by AstrazenecaDomestic pharmaceutical companies have developed a solvate modified drug for the SGLT-2 inhibitory diabetic drug Forxiga (Dapagliflozin, AstraZeneca Korea) and has entered into the application process. Once approved, the market sale will be available from April 8 2023, when material patents will be terminated. According to the MFDS on 3rd, the first approval application for Forxiga's solvate modified drug was received on 26th, and the patent holder, Astrazeneca was notified according to the licensed patent linkage system. The formulations requested for approval are Dapagliflozin L-proline and Dapagliflozin citric acid. The solvate is different from the Dapagliflozin propanediol hydrate of Forxiga. In the meantime, Korean pharmaceutical companies have been trying to avoid patents by changing solvates. In particular, the efforts were made to advance the release date by avoiding the extended period of 917 days for material patents. However, the plan was out of order with the ruling that salt-modifying drugs could not circumvent material patents with extended duration. Pharmaceutical companies, except for material patents, have challenged to follow-up patents (substance 2, formulation) and received an invalid or evasion decision this year. As a result, after April 7 2023, when the patent of substance is terminated, it will be possible to market the late drug. The initial license applicants are unknown, but as many companies have been patent-challenged, concurrent licensed products are expected to be poured out through commissions. Forxiga, used for the treatment of type 2 diabetes, is the first drug to be developed as an SGLT-T inhibitor. SGLT-2 inhibitors have a mechanism that lowers blood sugar by inhibiting glucose resorption in the kidneys, thereby promoting the release of glucose through urine. Insulin-independent mechanism of action is not affected by beta cell dysfunction and insulin resistance, so it can be used in combination with existing oral hypoglycemic agents. In particular, releasing sugar through the urine has the effect of weight loss. In some cases, it is known as diabetes medication that lose weight. Because of these advantages, Forxiga is leading the new trend in the diabetic market with outpatient prescription of ₩27.4 billion last year. Currently, SGLT-2 inhibitors include Forxiga, Suglat, Jardiance, and Steglatro, all of which are new drugs. Generic drugs are blocked from market sales due to original patents.
- Policy
- HIRA unveils listed drug reevaluation guideline
- by Kim, Jung-Ju Dec 05, 2019 06:14am
- Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team at HIRAThe government unveiled the details of the post-marketing reevaluation criteria and procedure of reimbursed drug. The scope of listed drug reevaluation mainly centers expensive drug items, such as anticancer and rare disease treatments, covered by insurance benefit despite their uncertainty in clinical efficacy. The evaluation borrows the previous reimbursed drug list adjustment procedure, but the criteria are to be set in more intricately to cover different kinds of pharmaceutical benefit provided now. Health Insurance Review and Assessment Service’ (HIRA) Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team under Pharmaceutical Department presented a post-marketing reevaluation plan on listed drug at a public hearing convened for the topic on Dec. 3 at the Ferrum Tower, Seoul. For the reevaluation, applicable items are to be selected from the pool of high-cost drugs treating cancer and rare disease with uncertainty in clinical efficacy. The selection procedure would take account of item’s insurance listing status in foreign countries, usage frequency, insurance billing ratio, namely pharmaceutical expenditure increase rate and billing amount. Also levels of pharmaceutical and medical importance and social interest could also affect the procedure. Initially selected list of drugs would then be evaluated by published literature, such as textbooks, guidelines and clinical literatures. Basically, the structure of the listed-drug post-evaluation is to follow the footsteps of the Moon Jae-in Care. Evaluation model the government used for adjusting reimbursed drug list from 2007 to 2011 ◆ Updating listed drug post-evaluation from 12 years back: Evaluation on clinical efficacy was a key evaluation model in the previous reimbursed drug list adjustment. Enforced from 2007 to 2011, the list adjustment procedure also made decisions on reimbursement listing cancellation or restriction based on literature review of related textbooks and guidelines, and verification of medically essential substances. The Level A clinical efficacy evaluation indicated an item is “clinically effective”, as long as it met at least one of criteria, including Health Technology Assessment (HTA), World Health Organization (WHO) Model List of Essential Medicines (EML), shortage prevention drug, orphan drug, basic parenteral solution, and other essential drug. Whereas, Level B evaluation indicated an item as “clinically effective” when it met all three criteria of confirming essential medicine recommendation by related academics, recognition by related committees, and usage status in foreign countries. In the past, the Korean government used to refer to the U.S. the U.K., France, Italy, Japan, Germany and Switzerland, also known as A7, for the status of reimbursement listing. For the evaluation, an item had to be listed in more than two countries from the list. A new drug developed from Korea or in Asia was considered ‘listed in two or more A7 countries.’ And now the government plans to apply the past experience in the reimbursed drug list adjustment procedure on to the new listed drug post-management. Considering the diversified pharmaceutical benefits since then, the new post-management system is expected to be segmentalized and tightened even more. New reimbursed drug post-marketing evaluation procedure model ◆ Evaluation details: From the overall list of reimbursed drug items, anticancer therapy, rare disease treatment and items with uncertainty in clinical efficacy would be selected as subjects for the evaluation. Further selection criteria consist of substances requiring clinical efficacy validation by reevaluating effectiveness, requiring tightened management due to change in population structure and increased usage volume, and requiring Post-marketing Drug Reevaluation Subcommittee’s evaluation considering impacts on the society and other healthcare issues. After the first phase of selection, HIRA would review foreign countries’ approval and reimbursement listing status on the subjects. Besides the list of seven foreign countries used for the past reimbursed drug list adjustment, Canada is newly added. Moreover, drug reimbursement billing amount, increased rate claims, billing frequency and its ratio are to be reviewed all around. Other factors like levels of pharmaceutical and medical importance and social interest would be added as the evaluation criteria. HIRA would then evaluate the filtered subjects with evenly chosen clinical literatures, such as related textbook, guidelines and HTA reports. The agency explained alternative treatment options and special property of substances would be considered as well. When choosing the textbooks and guidelines for the review, HIRA would extensively consider literature’s evidence basis, popularity, expertise, validity, publication period, language, and recognition based on academic society’s evidence evaluation. Currently, the government and HIRA have not finalized the detailed list of literatures, such as basic list of textbooks from major search database, list of basic guideline from foreign guideline search database, government-related or not-for-profit performance assessment report, and list of published Cochran Reviews and HTA report. In addition, HIRA is contemplating on taking account of substance demand from related academic societies, alternative feasibility based on available option with equivalent or different mechanisms, and special property of substance. Restrictive use for pediatric patient, treatment for special patients with HIV-like conditions, and emergent medicine are categorized as special property of substance. Clinical efficacy reevaluation procedure ◆ Procedure of clinical efficacy reevaluation: The government and HIRA are planning to select subject items with administrative review, Post-marketing Drug Reevaluation Subcommittee, and Drug Reimbursement Evaluation Committee (DREC), in the said order. The literature-based evaluation would follow the selection, and then the government agency is to officially notify respective pharmaceutical companies. The reevaluation can be repeated from the top, if need be, and the result is finalized after the second around. The government plans to subdivide the reevaluation procedure into finance-based and performance-based post-marketing evaluation, and further enhance the reevaluation procedure. Prospective plan for the reevaluation system
- Policy
- Opdivo label changes but reimbursed scope unchanged
- by Lee, Hye-Kyung Dec 03, 2019 05:55am
- Ono Pharmaceutical’s immunotherapy Opdivo’s (nivolumab) 240 mg dose secured an approval from the regulator and expanded scope of administration on the label, but apparently the treatment’s reimbursed level of dose would remain unchanged. Health Insurance Review and Assessment Service (HIRA) recently collected public comments on the revised ‘notice on medicine prescribed and used for cancer patients.’ The agency then clarified the insurance reimbursement would only be granted for Opdivo used to treat patients with non-small cell lung cancer or melanoma with dosing schedule of 3 mg/ kg every two weeks. It would be in effect from Dec. 9. After Ministry of Food and Drug Safety (MFDS) approved of Opdivo 240 mg in April, the immunotherapy received expanded approval on dosing schedule of ‘240 mg for every two weeks or 480 mg for every four weeks’ and added it to the label of Opdivo 20 mg, 100 mg and 240 mg, on Nov. 7. However, HIRA decided not to approve of reimbursement on the new dosing schedule as Opdivo’s clinical result did not demonstrate meaningful differences between several different doses. The agency explains because Opdivo 240 mg product is not listed for reimbursement, the cost-effectiveness of additional higher dose and administration is uncertain. “HIRA has decided to grant insurance reimbursement only for using the immunotherapy under the initial dosing schedule of ‘3 mg/ kg every two weeks’, as stated on the MFDS-approved label”, HIRA official said.
- Policy
- Hyperalgesia possibility if Fentanyl mucosa not control pain
- by Lee, Tak-Sun Dec 03, 2019 05:54am
- 대표적 펜타닐 점막투여제 Fentanyl mucosal drug, a typical narcotic analgesic used for the treatment of cancer patients, may not be controlled by hyperalgesia and resistance, will be reflected in the permit. This was done by the Agency by reviewing safety information from the European Medicines Agency (EMA). The permission change adds that fentanyl mucosal medications may cause hyperalgesia if pain is not controlled, and that dose reduction and discontinuation may be considered. In particular, new content is added to the usage and dosage located in the upper line of the permit. The additional phrase is, "If pain is not properly controlled, there is a possibility of hyperalgesia, tolerance and underlying disease progression, which should be taken into account." Hyperalgesia is an abnormally sensitive condition for a painful stimulus. In addition to the general precautions, "Optimal drug-induced hyperalgesia should be considered when there is a lack of pain control compared to increasing fentanyl doses, as with other opioids. Fentanyl dose reduction or discontinuation may be considered." Adverse events such as drug abuse and Synching Withdrawal Syndrome from postmarketing experience are also added. The MFDS asked for a review by December 12. Fentanyl mucosal drugs approved in Korea are 26 items in six companies, and the items are Narco Sublingual Tab. 200μg of BC World Pharmaceuticals, Actiq oral transmucosal tab of Hyundai Pharmaceuticals, Abstral sublingual tab of Menarini Korea, Daewoong Pharmaceutical's 'Instanyl Nasal Spray', Pharmbo’s Fentakhan sublingual tablet, Teve-handok’s Fentora Buccal tab. Of these, Fentora's sales amounted to ₩6.8 billion in 2018 and Abstral recorded ₩5.9 billion based on IQVIA.
- Policy
- HIRA rejects reimbursed use of Spinraza on 14-year-old
- by Lee, Hye-Kyung Dec 03, 2019 05:53am
- Approval on reimbursed use of Spinraza (nusinersen) on a 14-year-old male patient with 5q spinal muscular atrophy (SMA) was denied. The application submitted by the hospital was rejected as it did not clarify if the patient had developed clinical symptoms of SMA before 36 months. On Nov. 29, Health Insurance Review and Assessment (HIRA, President Kim Seung-taek) posted seven cases of Treatment Review and Evaluation Committee deliberation in October. Although Spinraza was listed on the Drug Reimbursement List from last April 8, a healthcare institute planning to use the treatment has to submit a preliminary drug use approval application due to the ultra-expensive maximum reimbursement price reaching 92,359,131 won per 5 ml vial. In last month, 15 preliminary drug use approval applications on Spinraza, including 13 first loading doses and two maintenance doses (application submitted once every four months), were submitted. But the committee disapproved only one case, which involved a 14-year-old boy. Other 11 first loading doses and two maintenance doses were approved, and one first loading dose was approved with conditions. The conditional approval was granted to a five-month-old female infant trying to get detached from ventilator. The committee approved of reimbursed use of Spinraza as long as the patient submits medical profession’s statement on use of ventilator prior to Spinraza administrations and medical record of respiratory function. Before the Spinraza review, the committee reviewed 34 preliminary applications on use of Soliris (eculizumab), including 23 cases of paroxysmal nocturnal hemoglobinuria (PNH) and 11 cases of atypical hemolytic uremic syndrome (aHUS). For the first loading dose, one PNH case was accepted and other one was rejected. Whereas three cases of aHUS patients were accepted and other three were rejected. Use of Soliris on a PNH case denied as the patient’s medical record was missing repetitive abdominal pain-induced hospital administration, but showed a recent increase in use of narcotic analgesic. The patient’s record did not meet scope of reimbursed use of the treatment. An aHUS case was rejected because the patient’s status was not clear cut as stated in the criteria. The patient’s symptom was considered as a secondary thrombotic microangiopahty induced from rheumarthritis and its treatment, and from multiple myeloma and its treatment. And also the patient showed rise of CEA level, delayed prothrombin time and activated partial thromboplastin time (PT/aPTT), and fall of fibrinogen level. The committee also decided the patient cannot expect positive effect from the treatment as the patient needs dialysis for end-stage renal disease. A preliminary approval review on reimbursed ventricular assist device (VAD) treatment was conducted as well. A male patient aged 64 years was registered on the heart implant waiting list with dilated cardiomyopathy (DCM), who was diagnosed with end-stage heart failure by an echocardiography with dobutamine substance and motor function test. The patient did not recover from medication treatment and is dependent on intravenous cardiotonic agent. HIRA approved reimbursement on the patient’s VAD treatment, because the case met the reimbursement standard of ‘indication for VAD implant on end-stage heart failure patient, who has been registered on heart implant waiting list as a makeshift treatment’. Also the patient not showing any contraindication helped the decision. Other details of the Treatment Review and Evaluation Committee’s October meeting can be found on HIRA website (www.hira.or.kr).
- Policy
- 'Ongentys' by SK Chemicals approved in Korea
- by Lee, Tak-Sun Dec 02, 2019 05:56am
- SK Chemicals obtained a domestic item approval for Parkinson's disease treatment,‘ Ongentys Capsule (Opicapone)’. This product is expected to be a new drug in the Parkinson's disease market after a long interval. The Ministry of Food and Drug Safety approved the marketing of SK Chemicals 'Ongentys Capsule 25mg, 50mg' on the 26th. This drug has been approved as an adjuvant therapy for levodopa/dopa decarboxylase inhibitors (DDCI) in patients with Parkinson's syndrome who have symptoms of locomotion that do not improve with levodopa/dopa decarboxylase inhibitor (DDCI) standard therapy. As a COMT inhibitor, it has a mechanism to improve the drug efficacy by increasing the plasma concentration of levodopa. Levodopa is a medicine that supplements dopamine, a brain neuron that Parkinson's patients lack. Ongentys has demonstrated efficacy and safety in a clinical trial in 1027 patients who are receiving Parkinson's treatment with levodopa/DDCI (alone or in combination with other anti-Parkinson medications) and who have symptoms of exercise fluctuations. Developed by BIAL, the largest pharmaceutical company in Portugal, SK Chemicals signed an exclusive sales contract with Bial in March 2018. Within a year since its first commercialization in Europe in 2016, the company is expanding its market rapidly, exceeding 10% market share in the same field market in Germany and Spain. The domestic Parkinson's disease drug market is estimated at ₩80 billion. As Ongentys is licensed as an adjuvant for levodopa, the market for product sales is expected to be smaller than the total market. Competitive drug 'Comtan' (ingredient name: Entacapone, Novartis Korea), which has a similar mechanism to Ongentys, recorded sales of 850 million won by IQVIA in last year. Comtan is also licensed as an adjunct to levodopa/dopa decarboxylase inhibitors, like Ongentys. An official of SK Chemicals said, "Ongentys will be a treatment alternative that will improve the motor agitation symptoms that are typical of Parkinson's patients". "We will strengthen our portfolio of central nervous system-related therapies to contribute to the establishment of a national health right," he said.
