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- 2026-04-13 10:24:09
- Opinion
- [Reporter’s View] Verify the oral COVID-19 treatments
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- Following COVID-19 vaccines, oral COVID-19 treatments are also expected to enter the market soon as the government plans to phase in 404,000 courses of COVID-19 oral antivirals from next February. If oral treatments for COVID-19 are introduced, Korea will have laid the groundwork for managing the COVID-19 virus like influenza. Also, clinical results for COVID-19 treatment candidates are being announced one after another. MSD's 'molnupiravir' was found to reduce the risk of hospitalization and death by 50% if taken within 5 days of symptom onset. Pfizer also released clinical results showing that ‘Paxlovid’ reduces the risk of hospitalization and death by 89% if taken within 3 days of symptom onset, and by 85% if taken within 5 days of symptom onset. The movement to introduce the drugs has also been speeding up abroad. On the 4th, the UK became the world’s first country to approve molnupiravir. The US FDA also plans to review the use of molnupiravir at the end of this month. The treatment is also set to be introduced in Korea from February through an advance purchase agreement. The faster the treatments are introduced the better, considering how late we were in introducing and commercializing vaccines compared to other countries at the end of last year. With legislation such as the Emergency Use Authorization established for the prompt introduction of such treatments, we will need to thoroughly prepare so that the oral antivirals developed abroad can promptly be imported for use in Korea. In addition to such prompt introduction, we would also need to pay close attention to and verify the oral treatments in advance so that the drugs may be safely used in Korean patients. This is a task for the Ministry of Food and Drug Safety. As the government announced that it will introduce COVId-19 treatments in February, the MFDS does not have much time for review. Therefore, MFDS would need to independently conduct its review and thoroughly verify the safety of the treatment in the limited time provided rather than rely on news of approvals from agencies abroad to reassure the public. In other words, now is the time for the government to take initiative. The government should proactively search for and persuade pharmaceutical companies to promptly introduce their COVID-19 treatments to Korea even if they have no plan to introduce the drugs to Korea yet. The reality is that Korea will have to depend on COVID-19 treatments developed overseas, just like the case was for the vaccines. Rather than focus on the commercialization of domestic COVID-19 treatments, the government should fully mobilize its administrative power to promptly introduce new COVID-19 treatments developed overseas.
- Company
- Expectations rise for Rinvoq in treating severe AD
- by Nov 10, 2021 05:55am
- A second JAK inhibitor has been introduced to the field of moderate-to-severe atopic dermatitis treatment. Abbvie’s ‘Rinvoq (upadacitinib),’ with its double advantage in improved convenience and effect, is heralding new change in the field of AD treatment. Rinvoq was additionally approved for the atopic dermatitis indication on the 6th last month by the Ministry of Food and Drug Safety. With the approval, Rinvoq is now approved for patients with moderate-to-severe atopic dermatitis in adults and adolescents over the age of 12. Rinvoq became the second JAK inhibitor after ‘Olumiant’ to be approved for atopic dermatitis. Also, the addition of Rinvoq increased the number of options for AD to three – the biological drug ‘Dupixent,’ and JAK inhibitors Rinvoq and Olumiant – in an area where no new drug had been introduced for a long period of time. ◆Dupixent’ targets specific cytokines – ‘Rinvoq’ provides broader inhibition Numerous inflammatory mediators are entangled like a web in atopic dermatitis, and Dupixent and the JAK inhibitor Rinvoq treat atopic dermatitis with different mechanisms of action. Dupixent selectively and potently inhibits IL-4 and IL-13, the key and central drivers of the type 2 inflammation that causes atopic dermatitis. It provides a higher effect by targeting specific cytokines, but also may not be effective in some patients. On the other hand, JAK inhibitors including Rinvoq provide broader cytokine inhibition. Cytokines bind to the cell surface receptors to deliver signals through the JAK-STAT and other signaling pathways, and JAK inhibitors target the JAK enzymes that command the protein that plays a pivotal role in immune/inflammatory regulation. Among the JAK enzymes, Rinvoq specifically targets JAK1, which not only includes IL-4 and IL-13, but also is involved in various other cytokines including the itch-specific cytokine IL-31, keratin-involved TSLP, IL-22 that thickens the skin, and interferon-gamma. ▲ Yong-hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine This mechanism of action is how RInvoq was able to show immediate effect in such a short period of time. At the RInvoq press conference that was held on the 9th, Yong-Hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine, said, “Inhibiting only IL-4 and IL-13 cannot be a complete solution to atopic dermatitis, as the immunopathological mechanism of atopic dermatitis is very complex, and manifests differently by race or age. The introduction of Rinvoq has resolved this unmet need.” Also, another difference between the two drugs that arise from the differences in mechanisms is in their method of administration. The biologic Dupixent is an injection and JAK inhibitors like RInovq are small molecule inhibitors that can be taken orally. Rinvoq can be a more convenient option for patients who have difficulty making regular visits to hospitals for injections. Oral drugs also have the advantage of allowing easier dosage adjustments fit for each patients’ condition. ◆Rises among JAK inhibitors with its superior data… achieves convenience in administration and effect Another advantage of Rinvoq is its excellent clinical data. In Phase III studies that compared RInvoq with placebo (Measure Up1, Measure Up2, AD Up), 60~70% of patients who received Rinvoq achieved EASI75 (at least a 75% improvement in the Eczema Area Severity Index) at Week 16. The proportion was 70-80% in patients who receive a higher dose (30mg). Also, 42-53% (higher dose 58-66%) achieved EASI90 (at least 90% improvement). Also, RInvoq significantly reduced itching, the symptom patients find most difficult to bear, in about half of the patients. 42~53% (Worst Pruritus improvement≥4) The results were more positive than the data from Olumiant, where about half of phase 3 participants reached EASI75. In addition, Rinvoq also demonstrated superior efficacy and safety in a head-to-head trial compared to Dupixent, which has the sole lead in treating moderate-to-severe atopic dermatitis. In the 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group ▲ Dong-hoon Lee, Professor of Dermatology at Seoul National University HospitalAlso, recently updated analysis data shows that switching from dupilumab to RInvoq had shown significant improvement. Dong-hoon Lee, Lee of Dermatology at Seoul National University Hospital, said, “Both the patients who showed response or no response to dupilumab showed significant improvement when switching from dupilumab to Rinvoq at Week 24 or later. And the effect continued until Week 52. The significant improvement in skin clearance and itching reduction even after switching was notable.”
- Policy
- The National Assembly speeds up the telemedicine bill
- by Lee, Jeong-Hwan Nov 10, 2021 05:55am
- With the government declaring a phased COVID-19, the National Assembly's Health and Welfare Committee is speeding up its review of amendments to the medical law, which temporarily introduces non-face-to-face treatment. The Welfare Committee plans to propose two amendments to the medical law aimed at legislating telemedicine at the plenary session to be held on the 11th and discuss whether to review the bill subcommittee. There are a total of two telemedicine bills proposed by the National Assembly: Kang Byeongwon of the Democratic Party of Korea and Choi Hye-young of the Democratic Party of Korea. Kang proposed the bill that telemedicine between doctors and patients is not allowed, but indirect medical practices such as non-face-to-face counseling are allowed through remote monitoring. Rep. Choi proposed a plan to allow telemedicine and non-face-to-face prescriptions and preparations only for vulnerable medical sites and vulnerable patients. The Welfare Committee is expected to complete the review of next year's budget by the MOHW, the MFDS, and the KCDA by the middle of this month, and immediately hold a subcommittee to review telemedicine bills. As the National Assembly speeds up telemedicine and non-face-to-face prescription and dispensing bills, related expert groups such as The KMA and the Korean Pharmaceutical Association are also paying keen attention to legislative trends. The KMA has formed a telemedicine response TF to start preparing countermeasures. The pharmaceutical society, which is set to hold the next pharmaceutical presidency election next month, has not formed a TF like the KMA, but is opposed to the legislation of telemedicine and non-face-to-face-to-face dispensing. The KMA, the KDA, and the Korean Pharmaceutical Association issued a joint statement last month and expressed regret over the revision of Kang Byeongwon and Choi Hye-young's medical bill. From the perspective of the pharmaceutical society, telemedicine legislation is a sensitive agenda in that it can promote the generalization of drug delivery and delivery platforms based on the activation of non-face-to-face dispensing. Kim Min-seok, chairman of the Welfare Committee, Kim Sung-joo, secretary of the Democratic Party, and Kang Ki-yoon, secretary of the People's Power, are coordinating the agenda of the subcommittee on bills.
- Company
- Ono's BTK inhibitor Velexbru was approved for sale
- by Nov 10, 2021 05:55am
- Onopharm (CEO Choi Ho-jin) announced on the 9th that it has received approval from the MFDS to sell BTK inhibitor Velexbrew as a monotherapy for patients with B cell-induced PCNSL. The first BTK inhibitor has emerged as a PCNSL treatment that has not yet been established. The basis for approval is the results of phase 1/2 clinical trials (ONO-4059-02) evaluating the efficacy and stability of Velexbrew in patients with recurrent or refractory PCNSL in Japan. The first efficacy evaluation index was ORR according to BICR. In this study, the ORR of the Velexbrew administered group was 52.9% (9/17 patients). The main side effects of grades 3 and 4 included neutropenia, leukopenia, and hyperneutral lipidemia, respectively, and 11.8% (2/17 patients).
- Company
- Non-reimbursed prescriptions for migraine drug Ajovy begin
- by Eo, Yun-Ho Nov 09, 2021 05:55am
- The new migraine drug ‘Ajovy’ is now being administered without reimbursement in Korea. According to industry sources, Teva-Handok Pharma’s Calcitonin gene-related peptide (CGRP) targeting migraine drug, Ajovy (fremanezumab), which was released in Korea on the 18th of last month, is now available for prescriptions at several medical institutions, including the Shinchon Severance Hospital. However, the drug has only passed a few drug committee (DC) reviews at general hospitals yet. Instead, the company had set a pre-order system for the drug for supply due to a flood of inquiries from patients whose symptoms recurred after taking Lilly's Emgality (galcanezumab)', another migraine drug that was released before Ajovy, also without reimbursement. Patients with severe migraines have shown expectations that Ajovy will bring different results based on the fact that the two migraine drugs have different dosages and methods of administration, although the two are from the same class. Emgality can currently be prescribed in medical institutions nationwide, in the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. Ajovy is administered two ways: 225 mg monthly, or 675 mg every 3 months (where 3 subcutaneous injections of 225mg are injected consecutively). The drug demonstrated its efficacy in the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 patients with episodic migraines (EM) and chronic migraines (CM). In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to a placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. 44.4% of subjects in the monthly dosing, 47.7% of subjects in the quarterly dosing group, and 27.9% in the placebo group showed a 50% or more reduction in migraine days. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and 4.3±03 days in the quarterly dosing Ajovy group, both were significant compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive therapies that had to be taken every day, patients may manage their migraines with once-a-month injection with CGRP targeted antibody drugs. The treatment cost remains an issue, however, we have high expectations for the drug because the more the patient receives the targeted therapy, the easier it is to treat."
- Company
- Will Ildong sell Nexium with annual sales of 50 billion won?
- by Kim, Jin-Gu Nov 09, 2021 05:54am
- Daewoong and AstraZeneca will terminate a joint sales contract for Nexium, a PPI-based gastroesophageal reflux disease treatment. The new joint sales partner of the large item, which generated about 50 billion won in sales last year, is said to be likely to be Ildong. According to the pharmaceutical industry on the 9th, Daewoong and AstraZeneca agreed to terminate the joint sales contract of Nexium last month. The contract is until December 31 this year. Nexium is a PPI-based gastroesophageal reflux disease treatment launched in Korea in 2000. Daewoong has been jointly selling with AstraZeneca since 2008. Sales have steadily increased over the next 14 years, making it the No. 1 item in the same ingredient market. According to the two companies, Nexium's sales reached 49.4 billion won last year. Instead of breaking up with Nexium, Daewoong plans to focus on sales and marketing of Fexuprazan, which is expected to be released next year. Daewoong is developing Fexuprazan, a P-CAB-based gastroesophageal reflux disease treatment. It is a drug of the same family as K-CAB of HK inno.N, which is rapidly growing in the market. Phase 3 clinical trials in 2019 have been completed. Currently, it has applied for item permission from the MFDS. It is also expected to be available as early as the end of this year. Daewoong Pharmaceutical has already been approved for generics with components such as Nexium in 2019. Starting next year, it is expected to sell Nexierd containing esomephrazole along with Fexuprazan. Ildong is said to be the most likely new co-selling partner of Nexium. Ildong is already jointly selling diabetes treatments such as Onglyza, Kombiglyze, and Qtern with AstraZeneca. On top of that, it is expected to further strengthen the combined front with AstraZeneca by jointly selling Nexus from next year. An official from Daewoong said, "The joint sales contract of Nexium will end at the end of this year," adding, "We decided not to extend the contract to focus on Fexuprazan, which is expected to be released next year." An official from the pharmaceutical industry said, "As far as I know, Ildong is likely to be the new partner of AstraZeneca, which will jointly sell Nexium," adding, "Unless there is a major change, the contract is expected to be signed soon."
- Policy
- Moderna vaccine produced by SB has been applied
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- The MFDS announced on the 8th that Moderna Korea has applied for permission to manufacture and sell the COVID-19 vaccine SPIKEVAX produced by Samsung Biologics in Korea. The vaccine induces an immune response by injecting antigen genes from COVID-19 in the form of mRNA to produce antigen proteins in the body. The MFDS announced that it will closely review the submitted quality, non-clinical, and clinical data and check the safety and effectiveness of the product to decide whether to approve it. An official from the MFDS emphasized, "We will continue to do our best to quickly supply safe and effective vaccines to the Korean people." Meanwhile, the COVID-19 vaccine developed in Moderna, USA, was approved for import items with SPIKEVAX on May 21.
- Policy
- LG Chem seeks approval for its ‘Zemiglo+SGLT-2i’ combo
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- DPP-4 inhibitor class diabetes drug developed by LG Chem LG Chem has applied for the marketing authorization of a combination drug that combines the DPP-4 diabetes treatment ‘Zemiglo (gemigliptin)’ with an SGLT-2 class inhibitor to the Ministry of Food and Drug Safety. With the new application, whether Zemiglo, one of the most successful locally developed novel drugs, will continue on its success with this new combination therapy is raising attention. According to the industry on the 7th, LG Chem recently applied for the marketing authorization of its dapagliflozin+gemigliptin combination therapy. The product name is known to be ‘Zemidapa,’ coined using the first letters of the two ingredients. LG Chem trademarked the name to the Korea Intellectual Property Office last month. In July last year, LG Chem received approval for a Phase 1 trial protocol that compares the pharmacokinetics, safety, and tolerance of gemigliptin 50mg and dapagliflozin 10mg administered separately and in combination. Also, in February 2020, the company was approved to conduct a Phase III trial that compares the efficacy and safety of metformin+gemigliptin+dapagliflozin with gemigliptin+metformin or dapagliflozin+metformin in Type 2 diabetes patients whose blood sugar level cannot be adequately controlled with metformin alone. The company applied for the approval of its combination drug to the MFDS based on the study results above. Dapagliflozin is the generic name of AstraZeneca’s SGLR-2 inhibitor, ‘Forxiga.’ The three DPP-4i+SGLT-2i combos currently available are all imported finished products. The products are Boehringer Ingelheim's ‘Esglito tab,’ AstraZeneca’s Qtern (saxagliptin monohydrate+ dapagliflozin propanediol hydrate),’ MSD’s ‘Steglujan (ertugliflozin l-pyroglutamic acid + sitagliptin phosphate hydrate). However, the products above have not been approved for insurance reimbursement, and therefore are not being sold fully in the market. However, reimbursement discussions on the drugs have made rapid progress recently, raising expectations that their prices will be listed soon. In fact, AstraZeneca had made joint marketing agreements for its Qtern with Ildong Pharmaceutical. Although no locally developed combo is available yet, DongKoo Bio applied for the approval of a citagliptin+ dapagliflozin combo in the first half of this year, raising the possibility that local products will also receive approval soon. Zemiglo is the 19th homegrown drug that was released in 2012. It recorded ₩35.9 billion in outpatient prescription sales last year. Zemiglo and ‘Zemimet,’ a combination of gemigliptin+metformin that recorded ₩79.9 billion last year, have been leading the domestic diabetes treatment market. The industry analysis is that a combination therapy that uses dapagliflozin will well show competitiveness in the market, as the market share of the gemigliptin ingredient is high in Korea's diabetes treatment market.
- Policy
- Will a recombinant flu vaccine be released in Korea, too?
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- The tetravalent flu vaccine supplied by Sanofi in Korea A gene recombinant influenza vaccine is expected to be released in Korea. Currently, flu vaccines made by using eggs or culturing cells are also on sale in Korea. The MFDS approved a phase 3 clinical trial plan for Sanofi's RIV4 vaccine on the 2nd. RIV4 is an abbreviation for Quardrivalent Recombinant Influenza Vaccine, which, in direct translation, is a quaternary recombinant influenza vaccine. This test is aimed at describing the immunogenicity and safety of quaternary recombinant influenza vaccines compared to quaternary inactivated influenza vaccines in 300 patients aged 18 or older in Korea. A tetravalent recombinant influenza vaccine has not yet been released in Korea. The recombinant influenza vaccine is a new concept vaccine that produces large quantities of antigen proteins cultured in plant-derived cells through gene recombination technology. The U.S. FDA approved Flublok developed by Protein Science in 2013, creating the first trivalent influenza vaccine. Sanofi acquired Protein Science for $650 million in 2017. In 2016, a quaternary recombinant protein vaccine developed by protein appeared, and in November last year, it was also approved by the European Commission. In the United States, the product name is Flublok, but in Europe it is called Supemtek. Sanofi is currently supplying a quaternary flu vaccine to Korea under the product name Vaxigriptetra. This product is a conventional inactivated vaccine using an oil well. So far, there are two types of tetravalent flu vaccines supplied in Korea: the oil well egg method and the cell culture method, and SK Bioscience's SKY Cellflu is a representative cell culture vaccine, and the rest are all fertile eggs vaccines. The quaternary recombinant influenza vaccine, which Sanofi conducts clinical trials in Korea, is known to have a higher preventive effect in the age group over 50s, including three times more antigens than those in oil fertilizer and cell culture vaccines. It is also an advantage that there are no vaccination restrictions on pregnant women or people with egg allergies. As Sanofi is also conducting clinical trials in Korea, industries predict that recombinant vaccines will be available as early as the 2022-2023 season. When a recombinant vaccine is released, the existing vaccine market structure is also expected to change.
- Company
- It is expected that the SGLT-2 combination will be activated
- by Eo, Yun-Ho Nov 08, 2021 05:52am
- Domestic approved SGLT-2 inhibitorsExpectations are also rising for revitalization of the combination drug market along with the expansion of combined benefits for the drug SGLT-inhibitors. According to related industries, pharmaceutical companies with SGLT-2 inhibitors and DPP-4 inhibitors, such as Beringer Ingelheim, AstraZeneca, and MSD, will go through the registration process of the complex when discussions on expanding the combined diabetes benefits are completed. However, it is expected that there will be differences in the actual registration speed due to the expiration of patents. ◆Esglito, co-developed by Beringer Ingelheim =Beringer Ingelheim and Lilly, is a combination of SGLT-2 inhibitor Jardiance and DPP-4 inhibitor Trajenta. Esglito was originally approved in Korea under the product name Glyxambi in 2017, but changed its product name at the beginning of this year. Currently, Jardiance has applied for an increase in benefit and is waiting for the HIRA's action. Beringer Ingelheim and Lilly's diabetes pipelines have been led by domestic promotion partners Yuhan Corporation. It remains to be seen whether Esglito will join Yuhan Corporation after the benefit issue has been resolved. ◆ AstraZeneca's Qtern= Unlike other complex, Qtern, combination of Forxiga (Dapagliflozin) and Onglyza (Saxagliptin) was launched in about four years. Ildong Pharmaceutical signed a domestic exclusive sales contract with AstraZeneca and began marketing and supply it in earnest from the 1st. Ildong Pharmaceutical is also expected to make decisions on Qtern if Forxiga's benefit is expanded. ◆MSD's Stegluzan=Stegluzan, combination of Steglatro and Januvia was released in October last year. MSD has also submitted an application for the expansion of Steglatro's combined benefits and is waiting for the HIRA's review. MSD plans to switch Stegluzan to release as soon as Stegluzan's benefit expansion is decided. A meeting of diabetes experts convened by the HIRA in September concluded in the direction of integrating and recognizing the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors. At the meeting, TZD-related drugs, which had cardiovascular side effects, were required to be judged by drug. Accordingly, prescription restrictions are expected to continue only for the combination of TZD. The HIRA is currently discussing the schedule for formal procedures, including the introduction of the Drug Reimbursement Evaluation Committee.
