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- 2026-04-17 06:15:02
- Everyone wants to develop COVID-19 treatment
- by choi, sun Mar 15, 2020 06:49pm
- #With regard to COVID-19, a number of pharmaceutical biotech companies have announced that they will develop treatments, and interest is being raised as to whether actual products will be available. Some pharmaceutical companies use abstract terminology such as clinical trials and treatment development, but vaccine development must be profitable first and vaccine development has failed in SARS and MERS in the past. Accordingly, some experts said that the expression should be carefully considered. According to an investigation by the KPBMA on the 12th, 15 pharmaceutical and bio companies have announced their intentions to develop COVID-19 treatment and vaccines 'officially'. SK Biosciences supported the discovery of non-clinical candidates for monoclonal antibodies for the treatment of COVID-19 promoted by the KCDC and GC Pharma also supported the development of a candidate for COVID-19 subunit vaccines based on synthetic antigens in the KCDC. It is too early to discuss the development of both companies as they will enter the stage of excavation as a candidate. Other than that, Boryung Biopharma, Sumagen, and G+FLAS announced that they would start developing the COVID-19 vaccine, but it requires a lot of basic technology, and there is no reality that can reveal the possibility of vaccine development. Experts point out that the reality is only a search for candidates applicable to COVID-19, but it is likely to be mistaken for the development of therapeutics and vaccines to promote Phase III. There are many companies that develop vaccines whenever new outbreaks occur, but they have actually started developing vaccines, but they have not succeeded. “An RNA virus constantly mutates through generations”, said an official from drug company B specializing in vaccines. Also, he added "Tens of billions of won are required to go through clinical trials to extract vaccines from infected people and attenuate the virus to make sure that the vaccine actually works for others". He says the current treatment and vaccine development news is exaggerated. In addition, considering the possibility of SARS strains, it is possible to draw conclusions that there are not many pharmaceutical companies that will execute billions of won to develop vaccines with high uncertainty. He said, "Any company is declaring the development of vaccines and treatments these days, but I personally think this is only an advertisement" and added that some companies have nothing to do with vaccines, they don't have the technology they have, but they say that they are developing vaccines". Among these, some companies are experiencing a strange phenomenon in which the stock price rises in the hope of the public that its own items can be used as a cure for COVID-19. An official pharmaceutical company A said, "There was an asthma treatment developed in the past, but I am cautious that the spread of COVID-19 would be mistaken for the company to develop a treatment for COVID-19". "In fact, pharmaceutical companies are not charities" said the official. "It only needs to be profitable to maintain, but now it feels like pharmaceutical companies are starting to develop real treatments and vaccines". Because of this controversy, the US FDA also issued a warning on the 9th. #A warning letter was issued for seven products that mentioned the treatment and prevention of a disease for a product that does not actually have a therapeutic effect. "There are currently no vaccines or drugs approved to treat or prevent COVID-19" said the FDA. "Vaccines and treatments under study are in development, but are in the early stages of development and have not been fully tested for safety or effectiveness". The FDA said that consumers should be wary of websites and stores that sell products that claim to prevent, alleviate, cure, diagnose, or cure COVID-19, and several companies claim to cure, alleviate, cure, diagnose, or prevent disease, but have not been proven. In clinics, COVID-19 is deteriorating as a marketing tool, and the sap with vitamins is being sold as an adjuvant. An official from bio company C that produces immune cell treatment products, said, "It is also promoted in a way that it can be safe from COVID-19 by boosting immunity with a single injection at clinics. It is only a supplement or a health functional food, but these are not therapeutic agents".
- Company
- “Lynparza now available for unmet medical needs in TNBC"
- by Eo, Yun-Ho Mar 13, 2020 06:32am
- Professor Sohn Joohyuk “Breast cancer has various treatment options.” True, but not always for all types of breast cancer. Since the release of Herceptin (trastuzumab), human epidermal growth factor receptor 2-positive (HER2+) breast cancer treatment paradigm has been shifted and follow-on targeted therapies are continuing to enter the market. The launch of Ibrance (palbociclib) has also brought new approach to hormone receptor positive (HR+) and HER2- breast cancer treatment scene. However, triple-negative breast cancer (TNBC), negative in all receptors including estrogen, progesterone and HER2, still has treatment needs unmet. For a long time, chemotherapy has been the only treatment option for TNBC. Although Roche’s targeted therapy Avastin (bevacizumab) has won the indication to treat TNBC for the first time in Korea, the treatment has not been listed for reimbursement, yet. And recently a targeted therapy option was introduced to the TNBC treatment market. AstraZeneca’s Lynparza (olaparib), first indicated to treat patients with ovarian cancer, has released tablet form and expanded its indication. Poly ADP ribose polymerase (PARP) inhibitor Lynparza has heightened the anticipation among patients with gBRCA-mutated TNBC, who have been treated with chemotherapy. Daily Pharm interviewed Professor Sohn Joohyuk of Medical Oncology Division at Severance Hospital about the effect of Lynparza. -What would be the reason behind sluggish development of TNBC treatment? Disease with clear biomarker has treatments developed accordingly, and also developing a treatment requires predictable marketability. 70 percent of breast cancer patients are HR+ patients, and 15 percent of breast cancer is HER2+. But TNBC patients only take up 15 percent of all breast cancer types. And even if a patient is categorized to have TNBC based on diagnosis of exclusion, they could be categorized again into various subtypes. With such diversity in breast cancer types, developing a treatment was surely challenging. But as most of breast cancer treatments these days are in development focusing on TNBC, we could expect to see more of new and promising findings in the future. -In the OlympiAD study, Lynparza-treated patient group demonstrated median progression-free survival (mPFS) of 7.0 months. It is arguable the difference against chemotherapy group with 4.2 months was barely noticeable, which proves the point the treatment for TNBC patient is highly difficult. Despite all, could we say the release of Lynparza is remarkable? It is apparent that TNBC itself is quite aggressive and expecting as effective treatment as HR and HER2+ treatment is not so easy due to diverse types of the cancer. The second-line therapy, after failing first-line therapy through existing anthracycline and taxane options, was limited to chemotherapy to treat TNBC. And because it was so limited that the median overall survival was at around one to 1.5 years. On the other hand, Lynparza has demonstrated significantly longer PFS in OlympiAD study, and response rate was also higher. From clinical point of view, high response rate is always considered crucial factor of consideration, so Lynparza can be viewed as a good option. -Based on the said clinical findings, Lynparza entered the market technically as a second-line treatment. Do you think it has the potential to become a first-line PARP inhibitor option? Sure. OlympiAD trial was designed to test on patients, who have been previously treated with anthracycline and taxane. The study combined patients taking first, second and third-line therapies. -Recently, immunotherapy Tecentriq (atezolizumab) has been approved as a fist-line therapy in combination with paclitaxel. As for a healthcare provider, now you are given two options. How would you utilize the options? For a patient diagnosed with BRCA mutation, I would first use PARP inhibitor on the patient who has been treated with anthracycline and taxane, as a supplementary therapy prior to a surgery. And because doctors have not reached a consensus on prescribing either immunotherapy or PARP inhibitor for TNBC patients, the effective treatment for respective patient could differ case by case. -If PD-L1 is expressed and BRCA is mutated simultaneously, would it possible to combine immunotherapy plus PARP inhibitor plus chemotherapy? At the moment, immunotherapy plus PARP inhibitor combination has an ongoing clinical study, but triple combination has not started a clinical study so it is not easy to say. -PARP inhibitor products in same class are launched one after another. Are there differences between those products? The reported clinical data between Lynparza and Talzenna (talazoparib) were not too far off. Their efficacy and safety profile could be considered on par. A candidate medicine, 'ABT-888' has unveiled meaningful clinical findings. But it is too early to talk about actually using the medicine at this point. Only because they are in a same class, it is not to say there is no difference. But the clinical data disclosed so far showed similar level of effect between Lynparza and talazoparib. -Do you agree Lynparza needs reimbursed prescription? The patients and doctors’ needs for Lynparza-like treatments have been unmet, and patients with TNBC lacked a good treatment option so far. To improve access to Lynparza, we need to both list the drug for reimbursement and improve access to BRCA mutation test. -Lastly, would you like to give us an advice on enhancing breast cancer treatment environment in Korea? To say the least, the current treatment environment has gotten much better. But it would be still helpful to build a better treatment environment by reflecting specialists’ opinions on apparent grey areas. For instance, there is a debate over the timing of using Herceptin, Kadcyla (trastuzumab emtansine), Perjeta (pertuzumab), and docetaxel. The mentioned drugs could be used after a year since the surgery as a supplementary therapy. While using trastuzumab, it is difficult to use TPH when the condition relapses or any other emergency occurs. And sometimes taxane has to be prescribed inevitably to use Kadcyla. More flexible reimbursement listing is needed to appropriate use available options. Although Korea has a wider choice of reimbursed options than in other Asian countries, the country lacks flexibility in listing reimbursement.
- InterView
- CEO Cho Jeong Woo “Cenobamate U.S. release is all ready"
- by Lee, Tak-Sun Mar 13, 2020 06:30am
- CEO Cho Jeong Woo of SK Biopharmaceuticals A new anti-epileptic drug from SK Biopharmaceuticals, cenobamate (U.S. brand name Xcopri), has set a new milestone in the Korean history of pharmaceutical industry history as it independently won an approval by the U.S. Food and Drug Administration (FDA). To this date, a new drug developed in Korea has been licensed out to foreign pharmaceutical sales companies before receiving approval from the U.S. or EU health authorities. So the Korean drug developers had no experience in processing overseas approvals by themselves. Moreover, SK Biopharmaceuticals plans to independently market the drug in the U.S. market. During a recent interview with Daily Pharm, President and CEO of SK Biopharmaceuticals Cho Jeong Woo said, “In the second quarter, 120 specialists in sales would release the product in the U.S. market. We have already established a sales network that could cover all regions in the U.S. at the same time.” Cenobamate also completed the last administrative procedure for the launch as the U.S. Drug Enforcement Administration (DEA) has designated the drug as a Schedule V medicine. DEA reviews FDA-approved central nervous system (CNS) medicine based on medical indication, and risk of abuse and dependency to categorize them into five levels (from Schedule I to V). And cenobamate received Schedule V for lowest risk of abuse. Accordingly, the level of pharmaceutical management on the drug would not be as stringent. Solely owned by SK Holdings, SK Biopharmaceuticals has fully emerged as Korea’s top new drug developing company after FDA granted approvals on solriamfetol, a new drug for sleep disorder licensed out to Jazz Pharmaceutical, and new anti-epileptic drug cenobamate. Daily Pharm asked CEO Cho Jeong Woo of what has been SK Biopharmaceuticals’ driving force to win two FDA approvals in a year and to independently launch a drug in the U.S. market. Following is CEO Cho’s answer to Daily Pharm’s questions. Q. Cenobamate has received the FDA approval in last November, and was nominated for the 21st Korea New Drug Award. Please tell us about the development process of cenobamate. In 2001, the company explored candidate medicines with high potential for anti-epileptic drug and discovered cenobamate. Since then, the company took step-by-step process, including nonclinical study, Phase 1 to 3 clinical trials, preparation for new drug marketing approval application and post-review procedure. And last year, the U.S. FDA has approved the drug to treat partial-onset seizure for adults. The commitment to develop a new drug targeting the U.S. market was made from strategic call expecting that receiving the strict FDA approval and releasing it in the world’s largest pharmaceutical market would put us on an advantageous side. Now that we have the FDA approval, we plan to move forward to accommodate cenobamate to various countries’ approval regulation. Q. Please tell us in detail about the process of selecting candidate medicine, initiating clinical trial and applying for approval. Over 2,000 candidate medicines were explored from 2001, and cenobamate was selected as an investigational candidate. The drug’s clinical protocols for testing efficacy in anxiety and epilepsy were approved by FDA in 2005 and 2007, respectively. Studies were conducted to develop an innovative and new anti-epileptic drug. With over 1,900 patients, Phase 2, randomized, double-blinded, placebo-controlled trial (completed 2013 and 2015) and Phase 3, large-scale, multicenter, open-label trial (completed 2018) were conducted. On Nov. 21 of 2018, cenobamate submitted a New Drug Application (NDA) to FDA and acquired the agency’s approval on Nov. 21 of 2019 after a year-long review. In 2020, FDA also reviewed and cleared current good manufacturing practice (cGMP) on SK Biopharmaceuticals and SK Biotek that produces active pharmaceutical ingredient (API) of cenobamate. As a result, SK is now a full-fledged new drug developing company capable of researching, conducting clinical trial, manufacturing and sales. Q. The company is the first in Korea to independently handle candidate medicine exploration, clinical development, sales and regulatory approval process. What has driven the company to cruise on with the standalone development, despite the high-cost of global clinical trials and R&D? The biggest driving forces have been the ‘solid sense of purpose’ and ‘daring mind’ taking the road not taken. The R&D capacity was built on years of research, but also on the sense of purpose to develop a breakthrough anti-epileptic drug. And in the process, the company gained experience in developing global-scale new drug and confidence of new drug development by collaborating with global pharmaceutical companies on a different drug. To acquire global drug development capacity, SK also collaborated with multinational company on post-Phase1 development of Sunosi, which provided rich experience like the approval application procedure. From then on, we were confident enough to plan for a transnational clinical trial and took the ‘standalone development route,’ unprecedented at the time in Korea, by personally persuading Chairman Chey Tae-won. Q. Sources say the U.S. subsidiary SK Life Science is planning to release the drug in the second quarter. Could you elaborate on the commercialization plan in the U.S.? Cenobamate is aiming for the U.S market release in the second quarter. The company has finished planning for marketing strategies, hiring salespeople and setting direct sales network covering the whole U.S. market. Commercialization of the anti-epileptic drug would be executed through intricately designed marketing strategy as the existing options are mainly prescribed by neurologists. While there are approximately 13,000 working neurologists the U.S., some 120 neurology sales specialists, on par with the scale of sales force for other anti-epileptic drug, would promote the Korean-made drug everywhere in the U.S. Q. Is there any news about the drug in development for other parts of the world besides the U.S.? Is Korea one of them? To commercialize cenobamate in the European market, the company has signed USD 530 million worth license-out deal with Arvelle Therapeutics last year. We are planning to submit application for European market authorization approval by the end of June. Although we are solely taking care of commercialization in the world’s largest market in the U.S., we are marketing the drug in Europe based on strategic partnership with local companies to accommodate their diverse regulatory and marketing landscapes. As for Korean, Chinese and Japanese markets taking up over 90 percent of overall sales in Asian anti-epileptic market, the company is preparing clinical trial and other approval review procedure required for respective countries. Q. Aside from solriamfetol and cenobamate, is there any other highly potential candidate drug? SK Biopharmaceuticals have been focusing on CNS disease for last 27 years, and solidified distinctive pipeline in the industry. Another Phase 3 clinical trial is ongoing for cenobamate to expand indication to treat patients with generalized tonic-clonic seizure. Carisbamate, a Lennox-Gastaut syndrome (LGS) treatment, is currently in development but also received Orphan Drug Designation from FDA in 2017. A new candidate anti-epileptic medicine, SKL24741, is to start Phase I trial from this year as FDA cleared its IND in March last year.
- Company
- Vibramycin & Cefdana are out of stock
- by Jung, Hye-Jin Mar 13, 2020 06:30am
- Some of rescription medicines are sold out. In particular, since Vibramycin-N sold out 500 tablets units in 2018, it is expected that units of 100 tablets will be out of stock, which will cause inconvenience to the prescription site. According to the distribution industry on the 11th, the re-supply of both 100 tablets unit and 500 tablets unit of Pfizer’s Vibramycin 100mg has been delayed. Pfizer Pharmaceuticals delayed the re-supply time from January to May of this year. The reason for the supply delay is the production schedule of the manufacturer. Vibramycin 500 tablets units have been delayed in re-supply since 2018. As the 500 tablets units were sold out, it seems that the supply and demand of 100 tablets units have been unbalanced since November 2018. Both 100 units and 500 tablets units are currently out of stock. The supply of 100 tablets units of Daewoong Bio's antibacterial drug 'Cefdana' are also insufficient. Daewoong Bio asked hospitals and pharmacies to order 30 tablets units. Packaging of 100 tablets will be released after April 20th. Korea Pfizer's hypertension treatment, Nitropress 2ml/vial type is also out of stock. It is expected to be available again later this month. The supply of 10mg, 30mg, 50mg, and 60mg of Bisphentin CR cap, a central nervous system stimulant of Mundipharma, was temporarily discontinued. This is due to the export license delay for original developers in Canada, and supply is expected to resume after April 21st. Some prescription drugs and some OTC were discontinued. The decision was made to discontinue 10 bottles units of Pocral Syrup 10ml, by Hanlim’s psychotropic drug, Hanlim announced that supply was discontinued after the final arrival in the second week of April due to difficulties in maintaining product production by consignment company, Kolmar’s situation, consignment company. Pocral syrup 10ml units were released in June 2018 upon the request of many hospitals. However, the leak problem occurred again in the bottle and lid joint, and the company tried to improve it by changing the glass bottle specification and investing in nozzle equipment, but the problem was not resolved, so the decision was made to discontinue production. Samil Pharmaceutical's disinfectant 'Potadin Surgical Scrub' 7.5% 4L packaging is also discontinued. It is a generic drug for Povidone-Iodine solution. Pharmbio Korea announced that there is no plan to re-supply RIBON 150mg 1 tablet units, an osteoporosis treatment.
- Company
- The Thai government has eased regulations on fillers
- by Kim, Jin-Gu Mar 13, 2020 06:30am
- Export of Hyaluronic acid filler to Thailand becomes easy. This is due to the Thai government's classification of hyaluronic acid fillers as medical devices, not pharmaceuticals, in Thailand starting tomorrow (11th). It is expected that domestic companies' entry into Thailand will accelerate as related certification requirements ease. According to KOTRA (Korea Trade-Investment Promotion Agency) on the 11th, Thailand will change the supervision of Hyaluronic acid fillers from the current FDA's Drug Management Bureau to the Medical Device Management Bureau. The classification of products is changed to 'Licensed Medical Devices' from 'Risk or Specially Managed Drugs among Drugs'. According to the Thai medical device classification, licensed medical devices include contact lenses, disposable syringes, surgical gloves, condoms, and HIV diagnostic devices. However, it is limited to products intended for skin treatment. Fillers used in addition to skin, such as knee pain treatment, are classified as pharmaceuticals as in the past. Hyaluronic acid filler's export certification requirements will likely ease as the classification system is changed. In the case of pharmaceuticals, certification requirements for safety and effectiveness were more difficult than medical devices. To export drugs to Thailand, A license to manufacture, import, and sell drugs from the Thai FDA must be obtained, and separately, Certification from the Food and Drug Administration for individual drugs must be obtained, too. At this time, documents such as the results of the non-clinical and clinical tests, chemical composition, manufacturing formula, quality control, and labeling should be submitted. In the case of medical devices, it is the same to obtain manufacturing, import, and sales licenses. However, the required documents are the application for permission, the sales certificate proved by the producing country, and documents related to side effects. As of 2018, a total of 35,018 cosmetic non-surgery methods in Thailand were counted. The proportion of Hyaluronic acid filler treatment is 27.1%, the second after Botulinum toxin treatment (58.7%). Hyaluronic Acid Filler Import Trend in Thailand as of 2019 (Data: KOTRA)Last year, Thailand's imports of Hyaluronic acid fillers amounted to $255.3 million. The share of French fillers is the highest at 25.7%. It is said that some brands from France, Sweden and Canada have a high share. Korea's share is 6.5%, ranking seventh. The amount is $16.69 million. An official from Kotra predicted that the change in the classification system would be particularly beneficial for Korean pharmaceutical companies. An official of KOTRA explained, "To date, the market of Hyaluronic acid filler in Thailand has a very high share of brands in some countries such as France and Sweden". He said, “But this change would make it easier for Korea to export to Thailand, Especially, it is expected to act advantageously for entry of Korean products with excellent quality and competitive prices”. He said, "Europe and Canada do not have an FTA with Thailand, so they have to pay 30% of the general import taxes, but in Korea, the Korea-ASEAN FTA Agreement is applicable so that they can enter the Thai market without taxes". Among domestic pharmaceutical companies, Medytox, Daehan New Pharm, Yooyoung pharmaceutical, Dongkook, and Hugel have been confirmed to have entered or are entering the Thai filler market.
- Company
- Bukwang “Levovir as effective as Kaletra on COVID-19”
- by Lee, Seok-Jun Mar 13, 2020 06:30am
- On Mar. 10, Bukwang Pharmaceutical announced its new treatment for hepatitis B Levovir (clevudine) has demonstrated treament effect on par with HIV drug Kaletra, also used to treat COVID-19. According to the Korean company, Levovir has been tested in vitro on virus extracted from Korean COVID-19 patient’s samples. Kaletra’s active pharmaceutical ingredient was used as positive control group. In plaque reduction neutralization test and real-time PCR, Levovir showed similar level of treatment effect with Kaletra. Clevudine is antiviral agent developed by Bukwang Pharmaceutical. The drug was released as a fourth hepatitis B virus treatment in the world and first in Asia. As a nucleoside analogue, clevudine has a mechanism to inhibit replication of virus DNA. Bukwang Pharmaceutical official said, “Based on the findings, the company would discuss with Ministry of Food and Drug Safety about further development plan like follow-up clinical trial.”
- Company
- Venclexta will be prescribed in major hospitals soon
- by Eo, Yun-Ho Mar 12, 2020 06:07am
- Venclaxta, which is ready for insurance benefits, will be prescribed at a general hospital soon. According to the related industry, Abbvie's Chronic Lymphocytic Leukemia (CLL) treatment, Venclexta (Venetoclax), passed DC (drug committee) of 5 big major Hospitals such as Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, and Asan Medical Center. This drug is the first and only oral inhibitor of B-cell lymphoma-2 (BCL-2) in Korea. Recently, it concluded a drug price negotiation with the NHIS and is expected to be presented to the Health Insurance Policy Deliberative Committee. Reimbursed prescriptions will be available as early as April. Venclexta inhibits excessive expression of BCL-2 protein, which inhibits apoptosis in chronic lymphocytic leukemia, in which lymphocytes in the blood are significantly increased. It selectively binds to the BCL-2 protein and inhibits its function to induce apoptosis, a new mechanism of treatment that prevents cancer cells from proliferating and worsening abnormally. Authorization is based on the results of the M14-032 study for phase II clinical trial to evaluate the efficacy in patients with chronic lymphocytic leukemia who have a history of treatment with Imbruvica (Ibrutinib) or Zydelig (Idelalisib). As a result, the overall response rate (ORR) of 127 Venclexta-treated patients was 70%. According to the latest results, the number of leukemia cells remaining in the peripheral blood or bone marrow analyzed the patient group with a minimal residual disease (MRD), which is an indicator of the remission and risk of recurrence. In patients without disease, the median progression-free survival (PFS) was more than 2 years (24.7 months). Jin-seok Kim, professor of hematology at Severance Hospital, said, "The introduction of Venclexta has opened the way for patients who are old or have failed or relapsed to continue treatment".
- Policy
- Probe that detects COVID-19 was successfully made
- by Kim, Jung-Ju Mar 12, 2020 06:07am
- While global attention is focused on the development of 'COVID-19' therapeutics, government-level development research is also in full swing. The government has succeeded in producing specific proteins to detect these infectious antibodies. The National Institute of Health (President Jun-Wook Kwon) in the KCDC (Director Eun-Kyung Jung) announced on the 10th that it has succeeded in producing a protein for detecting COVID-19 antibodies, which is essential for developing antibody treatments for COVID-19 response research. This protein, called Probe, can detect and isolate COVID-19 antibodies. According to the researcher, the production of antibody-detecting protein enables specific detection of neutralizing antibody-producing cells (B cells) in the blood of recovering patients, enabling the production of COVID-19 antibodies. The National Institute of Health has established the immunofluorescence (IFA) method by collecting the blood of patients who have been cured in the meantime, and plans to purify various COVID-19 antigen proteins and establish a neutralization test to evaluate the efficacy of therapeutic agents. Currently, the National Institute of Health has conspired two times on 12 urgent issues for the treatment, vaccine, and diagnostic and clinical research of COVID- 19, and is promoting the development through cooperation research with academia and companies by laying the foundation for the development of therapeutic antibodies, discovery of vaccine candidates, clinical epidemiology and serological studies, expansion of drug use range, and rapid diagnosis. In addition, by securing this supplementary budget, the institute will develop animal models for vaccine research and treatment, and make efforts to develop blood system materials using plasma of recovery patients. Sung-soon Kim, director of Center for Infectious Diseases Research, said that research on the development of antibody therapeutics through the urgent issue and the development of blood system drugs through the supplementary budget will promote cooperation with external companies, academia, and the medical community to advance the development of COVID-19 treatments that can be clinically applied.
- Company
- “No changes in safety and efficacy of montelukast”
- by Kim, Jin-Gu Mar 12, 2020 06:07am
- Medical academics argue there is “no change in safety and efficacy of montelukast,” currently controversial with safety risk. Professor Kim Chang Geun (Director of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center and President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease) Director Kim Chang Geun of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center spoke on Mar. 9 at a roundtable with press. The President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease (KAPARD), Director Kim stressed “The neuropsychiatric event from montelukast has been labeled on the drugs since 2008, which the prescribers are already aware of.” On Mar. 4, the U.S. Food and Drug Administration (FDA) has announced it would require Boxed Warning on montelukast products, including Singulair and generics. The U.S. health authority took the action after learning many healthcare providers, patients and caregivers are unaware of mental health side effect, such as anxiety, depression, sleep disorder and suicidal thoughts. FDA also recommended the drug would be used for “only patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.” Montelukast is vastly used for patients with asthma and allergy. The used volumes in Korea and Japan are particularly high. Although the alternative options advised by FDA are inhaled steroid and antihistaminic medicines, Professor Kim Chang Geun explains the use of those options would highly unlikely in Korea. Following is his answers to interview questions. -How are patients and caregivers reacting to the news? “A patient asked about the warning and if it would be okay to use it. I answered there is no specific change to the drug’s state of safety or efficacy. The said side effects are not newly discovered. Rather, the medications have been used for over two decades. I reminded the patient to read about the listed side effects carefully.” -Please explain how has treatment for allergic rhinitis been prescribed so far “Montelukast was the go-to medicine. Depending on the symptoms, other medicines were added. Antihistaminic agent was prescribed for serious sneezing, and steroid was prescribed for serious nasal congestion. And if the allergic antigen was clear, then immunotherapy was provided as well.” -Basically, the FDA’s announcement recommended montelukast as a second-line treatment for mild case of allergic rhinitis. Could it affect the trend of prescription on mild case of allergic rhinitis? “The FDA announcement could be summarized to two points; think twice before prescribing the medication to patients with asthma and select other alternative for patients with mild allergic rhinitis. The key is prescription for rhinitis. FDA mentioned three medicines for alternative options—antihistaminic agent, inhaled steroid, and immunotherapy. “Personally, the tendency of my prescription would not change. We do not have that many options to choose from. Patients and caregivers are highly resistant to inhaled steroid in Korea. Healthcare providers also tend to steer away from it, because we are aware of even worse side effects. Antihistaminic medicines are hardly a treatment. And immunotherapy is for limited use only.” -How about leukotriene receptor antagonist instead of montelukast? “Pranlukast would be an option. But it hasn’t got the U.S. FDA approval, yet. Developed from Japan, the medicine is used in Japan, Korea, China, Turkey and Mexico, as far as I know. I heard of zileuton and zafirlukast. But technically, they have not been used at clinical scenes.” -Considering the medicine is indicated to treat pediatric patients over age one, should the parents with young patient worry more about it? “Along with the official statement, FDA has attached a related research result. It compared side effect prevalence between montelukast and inhaled steroid used to treat patients over six. The result is that there is not much difference found between those two. It is not easy to evaluate patients aged one to five. But, with my 20 years of experience in the clinical scene, I have not found such side effect.” -What do you make of the FDA’s decision? “I’m not trying to defend the medication. But what I can assure is that it does not mean a new side effect has been reported. The point of the action was to highlight the neuropsychiatric side effect, labeled since 2008 to be exact, for healthcare professionals and patients to be aware of it. There is no change in the medication’s safety or efficacy. The clinical professionals are well-aware of the side effects. I assume the medication could be used without a problem, as it has been to this date. “Moreover, FDA said the cause and effect has not been clarified, yet. It only stated such case has been reported. So a patient suffering from neuropsychiatric side effect has used montelukast, but it wasn’t the only prescribed medication. It could have been the steroidal medication that caused the event. The disease itself tends to affect mental health as well. Regardless of the prescription, patients complain of anxiety and depression.”
- Policy
- Study for effects of Truvada and Kaletra will continue
- by Lee, Jeong-Hwan Mar 12, 2020 06:06am
- The government plans to continue research on the effectiveness of COVID-19 therapeutic substances and patient administration through various methods such as clinical trials. Following the clinical approval of Remdesivir, It will continue to study the necessity of administering drugs that are expected to be effective in treating corona, such as antiviral drugs Truvada and Kaletra. Sung-soon Kim, director of Center for Infectious Diseases Research, said on the 10th in the COVID-19 related meeting of the National Assembly, said, “There are many opinions that antiviral drugs such as Truvada and Kaletra should be used for COVID-19 therapy and plan to promote it as a research project”. In addition, Yoon Il-kyu, a member of Democratic Party Party pointed out that in order to reduce the deaths caused by COVID-19, preparations for treatments such as Remdesivir, Chloroquine, and Kaletra should be thoroughly prepared. Representative Yoon said, "Remdesivir, ebola treatment, is expected to be put into treatment in the US soon. I wonder if Korea is preparing for it". Representative Yoon said that COVID-19 doesn't have a vaccine anyway, so the treatment is important. Also added he, “there are especially lack of chloroquine in Korea, and there is still insufficient data that Hydrochloroquine has the same effect as chloroquine. Government measures related to therapeutics are needed". Sung-soon Kim, director of Center for Infectious Diseases Research instead of Vice Minister Kang-lip Kim answered, “Remdesivir is being used in Korea for the treatment of COVID-19”. Chloroquine's domestic volume, etc., was reported after confirming the situation. Sung-soon Kim, director of Center for Infectious Diseases Research said, "Remdesivir is approved by the MFDS and is being administered at three hospitals in Korea". Kim said, “Chloroquine is not nationwide, but I heard some of them are taking medication when visiting the field in Busan”. Also, he added that there are many opinions that clinicians want to use antiviral drugs such as Truvada and Kaletra in COVID-19, and am willing to carry out the reserch project.
