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- 2026-04-16 11:26:58
- Policy
- 1 out of 8 Koreans prescribed with narcotic anti-anxiety
- by Lee, Tak-Sun Aug 14, 2020 06:21am
- In last year alone, one out of eight people in South Korea have been prescribed with narcotic anti-anxiety medications. On Aug. 12, Ministry of Food and Drug Safety (MFDS) informed a pamphlet on ‘Safe Use of Narcotic Anti-anxiety Medication’ would be disseminated with the relevant information found from its big data analysis on the use of narcotic anti-anxiety medications reported to the Narcotics Information Management System for year from April 2019 through March 2020. The informational pamphlet allows a prescriber to self-diagnose over-prescription of the narcotic anti-anxiety medication by comparing their number of patients with the medication prescription and the volume against the overall statistics. The pamphlet would provide 12 types of information to healthcare providers including overall prescription statistics (number and volume of prescription), top disorders and substances prescribed, comparison on prescription volume per patient, age limit on prescription, and overall prescription volume rank. In the past 12 months, total 6.6 million patients were prescribed with narcotic anti-anxiety drugs, which is about one-eighth of the population. In particular, more female patients (63.4 percent) were prescribed with the medication than male patients (36.6 percent), and the age group of 60s was using the medication the most (20.4 percent). Diazepam (3.19 million), alprazolam (2.66 million) and lorazepam (1.14 million) were the most prescribed substances, and total 1.05 million patients (15.9 percent) were prescribed with medication with a warning for either elderly patients or specific age group. MFDS official also stated the pamphlet would include information on propofol, zolpidem and appetite suppressant to promote adequate prescription of those narcotic medications. The official added an online pamphlet system would be established as well by coming December to provide prescription statistics and information to more medical professionals.
- Policy
- The right age to use KRW 2.5 billion SMA drug Zolgensma
- by Lee, Tak-Sun Aug 13, 2020 06:27am
- Novartis Prior to the South Korean health authority’s approval on Zolgensma, known as the most expensive drug in the world, Central Pharmaceutical Affairs Deliberation Committee discussed the appropriate age of the drug user. The manufacturer Novartis has applied for an indication to treat patients under the age of two, but the committee concluded the age bracket should be lowered due to lack of clinical data. Unlike the U.S. and Japanese health authorities indicated the drug to be used on children under age two, the Korean health authority would likely to indicate the drug to treat infants under one year or six months. The Ministry of Food and Drug Safety (MFDS) disclosed the minutes from Central Pharmaceutical Affairs Deliberation Committee meeting in last May discussing the designation of Zolgensma as an orphan drug. Developed by Novartis, Zolgensma is a spinal muscular atrophy (SMA) treatment and the company priced the drug initially at 2.5 billion won, which gave the drug the title of ‘the most expensive drug in the world.’ The U.S. Food and Drug Administration (FDA) granted approval on the drug in May last year. In Korea, Novartis Korea has submitted the health authority approval application in last February and it awaits the final approval. SMA is an autosomal recessive genetic disorder caused by mutations in survival motor neuron 1 (SMN1) gene that encodes the SMN protein. It is a severe disease that usually occurs in infants, which leads to death. The diagnosed patients are in dire need of treatment at the moment. Categorized into three types, the two-thirds of type 1 result in death before the age of two, and type 2 patients may survive until pre-school, but most of them needs assistance in wheelchair due to muscular disability. Infants with type 3 seem normal but the disease advances slowly. At the moment, the existing SMA treatment in the market is Biogen’s Spinraza. Approved in 2017, Spinraza was also a vastly expensive drug priced at about 100 million won per administration. Although Spinraza has to be administered three to four times a year for a number of years, Zolgensma is a gene therapy administered only once. In last May, Central Pharmaceutical Affairs Deliberation Committee reviewed the subject patient’s age and treatment initiation period as requested by Norvatis. The company suggested using the drug on SMA patient under the age of two, but the committee members were against it. A committee member noted, “For clinical purposes, a variety of options is always welcomed, but Spinraza has been developed and the government should carefully decide whether to indicate the drug for ‘age under two’ or not, as the long-term clinical data on the drug’s efficacy and safety are insufficient.” Another committee member explained, “It would seem more appropriate to set the subject patient’s age as under one year or six months.” The chair of the committee also said the manufacturer’s request was not appropriate, so the patient age and type should be limited more. Instead of conventionally deciding the treatment period based on the types, the committee saw it would be appropriate to use a new categorization to administer the drug in patient with or without the symptom (diagnosed by gene testing). The committee also urged MFDS to consider the drug significantly improving the convenience of administration method as a gene therapy, although it cannot clearly prove improvement in safety and efficacy compared to the existing treatment option. Currently, about 17 patients under the age of two are diagnosed with SMA annually in Korea. The next concern for the drug is its high price. As the reimbursement listing process for Spinraza was a long and tough race, the health insurance authority would also have to expect the world’s most expensive Spinraza to bring even a tougher process.
- Company
- Kynteles is added in the revision of the domestic guidelines
- by Eo, Yun-Ho Aug 13, 2020 06:25am
- Kynteles is expected to be recommended as the first line therapy in the domestic IBD guidelines. Kim Joo-sung, president of the KASID( Department of Gastroenterology, SNUH), guided domestically at a press conference to commemorate the expansion of insurance coverage for the first-line treatment of Inflammatory Bowel Disease (IBD) of Takeda's 'Kynteles (Vedolizumab)' held on the 12th. Until now, in Korea, it had to be used secondarily only to patients who failed the TNF-α inhibitor according to the requirements. However, as the indications were expanded as the first-line treatment at the beginning of this year and the reimbursement was obtained On the 1st, it can be used as a first-line treatment in Korea, regardless of using TNF-α inhibitors. Kynteles, the only anti-integrin drug among the first-line treatments for IBD licensed in Korea, blocks inflammatory cells entering the intestine by a mechanism that specifically binds to α4β7 integrin of white blood cells that induce intestinal inflammation. In other words, the risk of tuberculosis or infection is lower than that of conventional treatments because there is no confirmed systemic immune suppression effect and only works in the intestine. Global guidelines also reflect this. In February, the guidelines published by the American Gastrointestinal Association (AGA) suggested strategies for inducing remission in outpatients with moderate or severe ulcerative colitis, depending on whether or not treated with biological agents. For patients without biologic treatment experience, conditional recommendations were given to Kynteles or Remicade (Infliximab) rather than Humira (Adalimumab) for remission induction. Kim Joo-seong said, "The more available treatments, the more likely the medical staff will treat patients safely and effectively. The domestic guidelines have also been revised. As Kynteles can be prescribed with benefits for first-line therapy in Korea, This will be actively reflected in the new guidelines. Meanwhile, Kynteles proved its effectiveness through a VARSITY study that directly compared with Humira. According to the results of the study, the clinical remission† rate of patients treated with Kynteles was 31.3% at 52 weeks, and the clinical remission rate of Humira was 22.5%. In addition, 39.7% of the patients treated with Kynteles showed the effect of healing the intestinal mucosa, whereas only 27.7% showed the effect in the control group.
- Policy
- There are 13 COVID-19 treatments in domestic clinical trials
- by Lee, Tak-Sun Aug 13, 2020 06:25am
- Currently, there are 9 antiviral drugs and 4 immunomodulatory drugs for COVID-19 treatments currently in clinical trials in Korea. As antiviral drugs and immunomodulatory drugs have different mechanisms of action, treatment methods are also different. The MFDS said that two clinical trials (Rebif, GX-I7) were added since the announcement on July 22, and a total of 20 (18 treatments and 2 vaccines) were approved in Korea by the 11th. Of these, five clinical trials for treatment have ended and there are currently 15 clinical trials in progress (13 treatments and two vaccines). COVID-19 treatments that have been developed so far are largely divided into 'antiviral agents' and 'immunomodulators' depending on the mechanism of action. Antiviral drugs are most commonly developed as medicines that remove viruses that cause infection. A representative example is 'Remdesivir', which was recently approved. Immunomodulators are drugs that show therapeutic effects by regulating the immune function, and are being actively developed as the main cause of death of COVID-19 patients is acute respiratory distress syndrome (ARDS), which causes excessive immune and inflammatory reactions. Antiviral drugs remove or weaken the virus in order to block the infection of the virus that has entered our body. Looking at the virus' infection process, the virus introduced into the human body penetrates into cells through receptors on the cell surface, creates a large number of new viruses in the cell, and the newly created virus comes out of the cell and penetrates into other cells, Antiviral agents that are currently being developed show an effect by blocking the path through which the virus penetrates into the cell during this process or by blocking the proliferation process that makes genetic material within the cell. Alvesco, Levovir, Pyramax, Nafamostat (Futhan, CKD-314), Camostat (CG-CAM20, DW1248), CT-P59, and Interferon (Rebif), which are currently in clinical trials, are expected to block the COVID-19 virus. In the case of 'Alvesco', it is expected to exhibit both antiviral and anti-inflammatory mechanisms of action. Immunomodulators include anti-inflammatory and immune enhancing agents. Anti-inflammatory drugs suppress the inflammatory response by regulating excessive immunity caused by COVID-19 infection. When the immune response occurs excessively due to infection by the virus, a lot of substances (cytokines) that cause inflammation are secreted, and the inflammatory response increases abnormally, damaging normal cells such as lung tissue, leading to acute respiratory distress syndrome, resulting in insufficient oxygen in the body. Anti-inflammatory drugs prevent damage to normal cells by inhibiting substances (cytokines) that cause excessive inflammatory reactions, such as 'Baricitinib, Ferodil, EC-18, and Alvesco', which are currently in clinical trials. On the other hand, an appropriate immune response inhibits viral proliferation and removes cells infected with the virus, and it is reported that some patients with low immunity are vulnerable to virus penetration. In this case, immunity enhancing agents that increase autoimmunity can help prevent or recover from disease progression, and 'GX-I7' is currently approved for a clinical trial plan based on this mechanism. Antiviral drugs such as Ivermectin, Camostat, and Interferon, and immunomodulatory drugs such as Dexamethasone, Tocilizumab, and Sarilumab are being developed for the treatment of COVID-19 abroad. An official from the MFDS said, "We will continue to monitor development trends such as clinical trials of COVID-19 treatments and vaccines, and based on this, we can provide support for items required for domestic introduction, special imports, etc., and we plan to do our best to guarantee the treatment opportunities for our people."
- Policy
- 74% relying on imported substance at risk amid COVID-19
- by Lee, Jeong-Hwan Aug 13, 2020 06:25am
- While the domestic self-sufficiency of pharmaceutical substance has been constantly falling and 74 percent of the industry is relying on overseas-imported substances, experts warn the South Korean pharmaceutical industry may be at risk when the substance supply gets unstable amid COVID-19. They advise the Korean government should set out a plan to promote diversification of overseas substance supplier and domestic manufacturing of essential substances, as well as to tighten safety management of the imported substances. The experts also recommended the government to work on preventive measures as they had to revoke approved licenses on biopharmaceuticals like Kolon Life Science’ Invossa and Medytox’ Meditoxin. On Aug. 10, the National Assembly Research Service published Health and Welfare Committee edition of ‘National Assembly Audit Issue Analysis 2020’ and gave advices to the government. ◆Dependency on imported pharmaceutical substance worsens: Pharmaceutical substances can be categorized either as an ‘active pharmaceutical ingredient (API)’ expressing the drug effect or an ‘intermediates’ essential for making APIs. In last five years, Korea has been manufacturing 31.8 percent, 24.5 percent, 27.6 percent, 35.4 percent and 26.4 percent of pharmaceutical substances in year 2014 through 2018, respectively. Korea’s pharmaceutical substance dependency on imported substances is as high as about 74 percent. As of 2018, Korea has imported 33 percent of substances from China and 9.5 percent from India. The Research Service predicted the pharmaceutical substance supply in Korea would suffer a major setback if COVID-19 pandemic lingers longer and disturbs the supply. In fact, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) conducted a survey in last February and reported Korean pharmaceutical and bio companies have stocks of pharmaceutical substances lasting two to four months. In particular, the Research Service pointed out carcinogen contamination incidents occurred as the pharmaceutical companies neglected safety management in pharmaceutical substances although it can critically affect quality and safety in finished products. In November 2019, Ministry of Food and Drug Safety (MFDS) has fully investigated valsartan, ranitidine and nizatidine when impurity in synthetic substances was discovered. The National Assembly experts evaluate the pharmaceutical substance suppliers should be diversified and essential substances should be encouraged to be manufactured domestically. And they also advised the Korean pharmaceutical industry to enhance safety measure in imported substances as the industry is heavily dependent on overseas suppliers. The National Assembly Research Service recommended, “Some criticizes it is an excessive action to strengthen the management of substances imported from China and India, because of their low significance and risk. But if the pandemic prolongs or another novel infectious disease breaks out, then the lack of good quality substance supply could delay production of finished products in Korea,” therefore, “The government should induce the industry to diversify overseas suppliers to maintain a good flow of supply and to manufacture essential substances.” The researchers added, “MFDS has disclosed plans to reinforce imported pharmaceutical substance safety control by introducing pre-registration system on overseas substance manufacturer to confirm Good Manufacturing Practice (GMP) compliance and to perform on-site investigation for quality control and management,” and “These pharmaceutical substances need more attention as the industry is relying heavily on India and China for importation of 715 cases (25.6 percent) and 227 cases (9.9 percent), respectively.” ◆Tightening pharmaceutical assessment procedure: The National Assembly Research Service has also urged the government to draw up a plan to prevent incidents like revoking the license on osteoarthritis gene therapy Invossa and botulinum toxin medicine Meditoxin for manufacturing and selling drugs different from the verified item. The investigators not only reprimanded Kolon Life Science and Medytox for their unethical practices, but also criticized MFDS’ verification procedure. Accordingly, MFDS presented their plan to strictly investigate and penalize such data manipulation cases with zero tolerance policy. The researchers, however, pointed out the impact on patients’ safety should not be ignored regardless of MFDS stating the safety in Invossa and Meditoxin should not be a problem. As a solution, the researchers recommended the government to tighten the GMP compliance management and adding more information on precautions when license revocation and recall recurs. The National Assembly Research Service noted, “MFDS aims to conduct a randomized investigation even on drugs with first tier toxicity risk level to prevent data manipulation, and also raise the severity level of penalty on companies financially benefited from an item approved with data manipulation.”
- Company
- Quadrivalent Flu Vaccine for NIP, failed in bidding
- by Aug 13, 2020 06:25am
- The procurement of a tetravalent vaccine for influenza for NIP failed bidding three times due to an excessively low unit price. According to related industries on the 10th, two bids for the '2020-2021 season influenza vaccine purchase' conducted by the KCDC were failed on the 28th of last month. Initially, New Medipharm and PharmWorld (NIP, local government project, AI response, etc.) and Seojun Pharm (children, pregnant women) were each successful bidder, but both failed to submit a supply confirmation and gave up delivery. The government's low unit price setting is blamed as the reason for abandoning delivery. The government set the estimated unit price for a quadrivalent flu vaccine at ₩8,790. This is only 60% of the usual supply price of ₩14,000 to ₩15,000 for tetravalent vaccines. Even this is also somewhat increased due to the failure in bidding. At the time of the first bidding on the 2nd of last month, the estimated unit price suggested by the KCDC is ₩8,490. Wholesalers who did not receive a supply agreement from the manufacturer at an excessively low price eventually gave up supply. Accordingly, the government slightly increased the unit price to ₩8,610, but it was sold as a single bid. In the third bid, ₩8,790 was offered, but the final successful bid was not achieved. It is in danger of delaying the government's plan to complete the contract in July and begin purchasing in August with subsequent reservations to begin full-fledged vaccination from October. The government plans to conduct an urgent bid to purchase an influenza vaccine on the 13th, but the possibility of failing in bidding remains as it is applying the same unit price as the last bid. An official from the flu vaccine manufacturing industry said, "The government’s proposed tetravalent vaccine supply price is almost no difference compared to the trivalent vaccine price, which has a low production cost." Also, as the NIP supply price decreases, the difference between the supply price in the private market widens, which is a burden for manufacturers. This is because the greater the gap, the stronger the demand for price cuts in the private market will increase.
- Company
- Big 5 pass Qsymia powered by Alvogen-CKD co-marketing
- by Eo, Yun-Ho Aug 12, 2020 06:00am
- The Big Five general hospitals have cleared the prescription of Qsymia speedily widening its brand awareness within the obesity treatment market. According to pharmaceutical industry sources, the drug committees at Big Five hospitals like Seoul National University Hospital, Severance Hospital, Samsung Seoul Medical Center and Seoul Asan Medical Center have reviewed and approved the prescription of Qsymia supplied by Alvogen and its Korean co-marketing partner Chong Kun Dang. Seoul St. Mary's Hospital is also in the process of reviewing the drug. The prescription code has been landed in Korea University Anam Hospital, Ajou University Hospital and other major hospitals around the country. Qsymia can be prescribed in four different doses—3.75 mg/ 23 mg, 7.5 mg/ 46 mg, 11.25 mg/ 69 mg and 15 mg/ 92 mg—and their pricing have been fixed to 4,000 won per tablet. Belviq, Contrave and Qsymia’s cost per day are about the same in Korea and the U.S. A clinical study on Qsymia found the drug demonstrates the most superior effect in weight loss among the Food and Drug Administration (FDA)-approved long-term obesity treatments, and shows better safety than Saxenda or Contrave. The retrospective meta-analysis study comparing five drugs have reviewed 28 randomized clinical studies on 29,018 patients. Qsymia showed the best weight loss effect in losing over five percent of body weight, and Saxenda, Contrave, Belviq and Xenical followed in the order. The distribution of the drug effect in patients who have lost over 10 percent was also led by Qsymia (54 percent) and followed Saxenda (34 percent), Contrave (30 percent), Belviq (25 percent) and Xenical (20 percent). Saxenda and Contrave had the highest risk of halting the administration due to adverse reaction, whereas Belviq had the lowest. Qsymia’s level of risk was around the mid-way between Saxenda and Belviq. In just three months after the release, Qsymia generated 4.3 billion won in a quarter and seconded the obesity treatment market in Korea. The sales gap between Qsymia and Saxenda are only 1.6 billion won. The drug has already doubled the sales of Daewoong Pharmaceutical’s Dietamin, which has been tailgating after Saxenda until the fourth quarter last year. Qsymia is a phentermine plus topiramate combination drug developed by the U.S.-based Vivus, and Alvogen signed a deal in 2017 to supply the drug to Korea. Alvogen then inked a co-marketing deal with Chong Kun Dang in last year, and fully initiated the sales and marketing activities from early this year. Alvogen, with experience in obesity treatment sales like Furing and Furimin, have generated a synergy effect with Chong Kun Dang’s sales power for the obesity treatment to quickly take up the market. A pharmaceutical market research firm UBIST found Qsymia has made 310 million won and 614 million won in last January and February, respectively, and placed itself on the leader board following Saxenda (875 million won), Dietamin (847 million won) and Hutermin (780 million won) as of February.
- Policy
- 14 generics for Albendazole, were already approved this year
- by Lee, Tak-Sun Aug 12, 2020 06:00am
- Albendazole is on the rise this year. Albendazole is an anthelmintic ingredient that began to obtain domestic approval in the early 1980s, and only four products were approved from 2017 to 2019. However, as other effects other than the approval of Albendazole became known through social media, new licensed generics have rapidly increased this year. According to the MFDS, the number of Albendazole-based anthelmintic products licensed in 2020 was counted as 14 items (including two for export). There were 64 items approved as Albendazole by the 9th, and most of them were approved before 2010. In particular, from 2017 to 2019, there were only 4 licensed items. There are so many items, and the market size is limited, so the number of new items has not been much since 2010. However, this year, Albendazole has become so popular that there are out of stock, and attracting the attention of pharmaceutical companies. This is due to a phenomenon that occurred when rumors, such as that Albendazole has anticancer effects, spread through SNS such as YouTube. Following anthelmintic 'Fenbendazole' for dogs in last year, 'Albendazole' in this year has become the center of this phenomenon. Moreover, as information that it is effective against the COVID-19 spreads, sales volume is increasing rapidly this year. In particular, Albendazole is an over-the-counter drug, and because it can be easily purchased at pharmacies, more and more people believe in rumors to purchase. As demand exploded, it was difficult to obtain Albendazole at pharmacies for the past six months. Albendazole's popularity has not declined, even though the MFDS and the Medical Association warned in January that its use for purposes other than treating parasitic infections was very inappropriate. The MFDS said, "Albendazole is a drug that is approved for short-term use for anthelmintic purposes. It is not safe for the human body when taken for a long period of time. There is a risk of fatal side effects or seriously impairing the effectiveness of the existing treatment. Patients undergoing treatment for severe diseases such as cancer or chronic diseases such as diabetes are at risk of causing fatal side effects or seriously impairing the effectiveness of the existing treatment.” However, it is analyzed that the existing Albendazole supply shortage continues, and new product approvals are being followed.
- Company
- Sayana and Gonal-F shortage may last longer than expected
- by Aug 12, 2020 05:59am
- Shortages in various drug products are reportedly caused by manufacturing facility changes and unstable supply of pharmaceutical substances. According to pharmaceutical distribution industry sources on Aug. 10, Pfizer Pharmaceutical Korea, Merck Korea, Dalim Biotech and other companies have recently informed of shortages in some products. Pfizer Pharmaceutical Korea notified of halting supply of an injected female contraception Sayana (104 mg/ 0.65 mL) from coming October. The subcutaneous injection is currently indicated for contraception or pain from endometriosis in female patients. The global company explained the unstable production delay in the manufacturing facility would prolong the shortage. The final batches of supply are to be expired on May 31, 2023. Merck Korea’s self-injected fertility treatment Gonal-F Pen (300/ 450/ 900 IU) would also experience temporary shortage due to delay in supply. Apparently, the QC schedule in Korea was postponed. Merck Korea stated, “The supply would be ceased around Aug. 10,” but “It would resume around second or third week of September. And more accurate schedule would be notified again in late August or early September.” The importation schedule for Menarini Korea’s diuretic Torem 2.5 mg tablet has been pushed, because the company is changing the overseas manufacturing facility. The supply is expected to resume from Sept. 4. Regardless, Torem 5 mg or 10 mg tablets would be supplied normally. Dalim Biotech issued a notice on temporary shortage in Norpin 20 mL injection due to reevaluation on the transferred manufacturing facility. Dalim Biotech official noted, “As the company moved its manufacturing factory, the health authority has also been changed from Gyeongin Regional Office of Food and Drug Safety to Seoul Regional Office of Food and Drug Safety. And the health authority requested reevaluation on Norpin,” accordingly, “The product would likely to experience temporary shortage until the Ministry of Food and Drug Safety (MFDS) completes the evaluation.” The shortage is expected to last about a month, and the normalized supply would resume from late August to early September. With the manufacturing factory transfer, Dalim Biotech is also having a temporary shortage in a diabetic nephropathy treatment Lipo-A tablet 30T. However, Lipo-A tablet 500T is in supply. Meanwhile, Ildong Pharmaceutical’s OTC digestive Soxinase Triple tablet 300T and Korea United Pharm’s hypertriglyceridemia treatment Omethyl QTlet 2 g soft capsule are also out of stock at the moment as the companies are dealing with problems in substance supply. Currently, the two companies do not have specific dates for the resumption of the product supply.
- Policy
- Genexine, conducts clinical trials of 'GX-I7'
- by Lee, Tak-Sun Aug 12, 2020 05:59am
- #Interleukin-7 anticancer drug candidate, being developed by Genexine, will conduct a clinical trial in Korea in patients with COVID-19. The MFDS announced on the 7th that it has approved a phase I clinical trial plan for 'GX-I7', a domestically developed COVID-19 treatment. As a result, there have been a total of 15 clinical trials (13 treatments, 2 vaccines) of treatments and vaccines currently in progress in Korea related to COVID-19. 'GX-I7', which was approved this time, is a 'gene recombined human interleukin-7' drug that is being developed as a new anticancer drug by 'Genexine' and was developed through drug Repositioning. The product will be evaluated for safety in a clinical trial in healthy people at the time of development of the anticancer drug, and in this clinical trial, the safety and preliminary efficacy will be evaluated in patients with mild COVID-19 infection. GX-I7 increases autoimmunity by proliferating immune cells (T cells) of COVID-19 infected patients, preventing serious progression or helping recovery. 'Interleukin-7' developed by company R in the United States is undergoing clinical trials in patients. An official from the MFDS said, "As there is great public interest in the development of COVID-19 treatments and vaccines, we will continue to promptly deliver information on the status of clinical trials of domestically developed products. We plan to support as much as possible so that it can be developed quickly.”
