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- 2025-12-26 19:25:59
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- Orally taken Rinvoq to be prescribed in general hospitals
- by Eo, Yun-Ho Dec 18, 2020 06:07am
- A third Janus kinase (JAK) inhibitor in South Korea, Rinvoq is swiftly seeking for prescription authorization in general hospitals nationwide immediately after it was listed for the healthcare reimbursement. An industry source reported AbbVie’s Rinvoq (upadacitinib) has been recently passed by the drug committees (DCs) at Seoul Asan Medical Center, Chungnam National University Hospital, Inje University Haeundae Hospital, Hanyang University Hospital, Seoul Medical Center, Kangbuk Samsung Hospital, Wonkwang University Hospital and Sahmyook Medical Center. Listed by the South Korean health authority for reimbursement since Nov. 1, Rinvoq is indicated to treat adult rheumatoid arthritis patients, who qualify the diagnostic criteria set by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR); patients whose Disease Activity Score (DAS) 28 exceeds 5.1, or over 3.2 and under 5.1 but has developed joint damage confirmed by image exams; patients who did not respond sufficiently to two or more types of anti-rheumatic drugs including methotrexate (MTX) for three months each and six months total, or who halted the treatment due to adverse reaction. Rinvoq was able to earn the reimbursement approval by using the approval-reimbursement linkage system and accepting the weighted average pricing of an alternative drug. Only five months after the official marketing approval was granted in last June, the drug received the healthcare coverage. The industry predicts the general hospitals clearing the prescription code would fully open up the market for the drug. Regarding the treatment for an autoimmune disease, the interest on a JAK inhibitor, such as Xeljaz (tofacitinib), Olumiant (baricitinib) and Rinvoq, has been growing as it is the first to offer an oral option with confirmed effect equal to anti-tumor necrosis factor (anti-TNF) drugs to the patients. .However, the JAK inhibitors’ impact in the market has not been too prominent as other biologics .Compared to the market leader anti-TNF drug and popular anti-interleukin drugs, JAK inhibitors’ indications are limited to rheumatoid arthritis and few other diseases .The first-in-class Xeljanz has expanded its indication to treat ulcerative colitis and psoriatic arthritis, and other follow-on drugs have ongoing studies to expand indication in autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylosing spondylitis .Rinvoq has demonstrated its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY) .The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira (adalimumab) .An internal medicine professor at Hanyang University Rheumatoid Hospital, Dr .Kim Tae-hwan commented, “Rinvoq was able to reach a level of clinical remission improved than the existing standard of care during a clinical trial conducted on various groups of patients .As it also demonstrated an improved effect of reducing pain, patients may anticipate daily life free from pain, joint damage and faltering cognitive function with the help of the reimbursed option of Rinvoq.”
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- When will K-COVID-19 vaccine be released?
- by Kim, Jin-Gu Dec 18, 2020 06:06am
- As Pfizer's COVID-19 vaccination has begun one after another in the UK and the US, interest in domestic companies that have jumped into COVID-19 vaccine development is also increasing. Currently, it is predicted that the commercialization of vaccines developed by domestic companies will be possible only in 2023 even if the commercialization is early. ◆Four domestic companies were clinically approved, results announced in 2023 According to the MFDS on the 15th, five companies and institutions in Korea have been approved for clinical trials for vaccine development. International Vaccine Research Institute (IVI), Genexine, SK Bioscience, Geneone Life Science, Cellid, etc. IVI is conducting global clinical trials of INO-4800 being developed by the US pharmaceutical company Inovio in Korea. However, in the case of IVI, additional information on phase II/III of clinical trials was requested from the US Food and Drug Administration (FDA). There are four domestic companies including Genexine, SK Bioscience, Geneone Life Science, and Cellid. All four companies are in the early stages of development. Genexine, Geneone Life Science, and Cellid are in Phase I/IIa, and SK Bioscience is in Phase 1. According to the MFDS, their target clinical completion is in 2022. ◆Genexine changes candidate substances and starts again from Phase I Genexine was approved by the MFDS on June 11, as a substance called GX-19. On September 4th, it is confirmed that the patient recruitment was successful. However, it is estimated that the clinical results were not satisfactory. Genexine recently announced that it will restart clinical trials by changing the candidate substance to a substance called GX-19N. According to the revised clinical plan, Genexine will re-challenge in Phase I/IIa, targeting 170 people at 8 locations including Severance Hospital and Gangnam Severance Hospital. As Genexine starts again from Phase I, the results are expected to be delayed by 2-3 months. The target date for completion of the clinical trial that Genexine originally submitted to the MFDS as GX-19 was June 2022. According to Genexine's description, the results of Phase I/IIa will be released only in August 2022. However, there is a possibility that the vaccine will be commercialized earlier if the results of phase I/IIa are obtained earlier. The target date for completion of the first results of clinical I/IIa announced by Genexine is March 17, 2021, and the initial clinical results will come out from May to June next year, considering the delay of 2-3 months due to the change of candidate substances. Based on this, it is explained that if phase III clinical trials are initiated promptly, there is a possibility of completing phase III within next year as planned by Genexin and the government. Jun-wook Kwon, head of the 2nd vice president of Central Disease Control Headquarters, explained at a regular briefing on the 15th, "We will discuss with the pharmaceutical company managers at the Therapeutic Vaccine Specialized Committee on the 16th. We will proceed with the goal of completing phase III clinical trials of domestic vaccines by the second half of next year." . ◆SK·Geneone Life Science· Cellid, commercialized after 2023 The development status of domestic companies is in contrast to the fact that 57 global pharmaceutical companies are in the final stage of vaccine development. According to The Korea National Enterprise for Clinical Trials, there are a total of 127 COVID-19 vaccine clinical trials in progress worldwide on the 15th. Of these, 57 cases (45%) entered Phase III. It has entered the final stage of clinical trials less than a year since development began. For example, in the case of Pfizer, vaccination has already begun in the United States and the United Kingdom after receiving urgent approval from the FDA. For Modena, FDA approval is expected as early as this week. AstraZeneca and Johnson & Johnson are looking for approval early next year. Of course, it is not worthless that the timing of vaccine commercialization is delayed compared to global pharmaceutical companies. An official in the pharmaceutical industry said, "We do not know how many years the immune effect of vaccines developed by Pfizer and others will last. If we succeed in developing products with improved effectiveness, safety, and convenience, it will be sufficiently competitive."
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- Drug export breaks record making near KRW 7 trillion
- by Kim, Jin-Gu Dec 18, 2020 06:05am
- The South Korean-made pharmaceutical export broke the record this year. The accumulated export volume up to November has already exceeded the total export volume in last year. Due to a steep surge in pharmaceutical export, the industry trade performance is expected to hit the highest point in the history. According to the Korea Customs Service on Dec. 15, the cumulative pharmaceutical export in November reached USD 5.89 billion (approximately 6.44 trillion won). Keeping up the inclining trend, the figure could even hit 6.4 billion dollars (7 trillion won) by the end of the year. This year has already recorded the highest pharmaceutical export volume. Even since August, the accumulated export volume has passed the last year’s total export volume 3.70 billion dollars (approximately 4.4 trillion won). Yearly volume of pharmaceutical export reported by the Korea Customs Service (Unit: USD 1 million) As of November this year, the pharmaceutical import volume marked 6.82 billion dollars (approximately 7.42 trillion won). Compared to the same 11 months last year generating 6.01 billion dollars (approximately 6.55 trillion won), this year’s figure was increased by 13 percent. The import volume is expected to increase up to 7 billion dollars by the year end. But as the export volume skyrocketed compared to the import volume, the gap between the pharmaceutical import and export is also expected to narrow down the most in the history. The last year’s import and export had deficit of 2.98 billion dollars, which was lowest since 3.21 billion dollars in 2014. The deficit in this year as of November was 911 million dollars. Since 2010, the pharmaceutical trade deficit was constantly above the 2.5 billion dollar-line. Yearly trade balance in pharmaceutical products reported by the Korea Customs Service (Unit: USD 1 million) By month, the trade balance made surplus four times this year. The trade surplus of 40.38 million dollars, 6.28 million dollars, 82.90 million dollars ad 65.25 million dollars were reported in May, August, September and November, respectively. Ever since the industry statistics were collected, the monthly trade balance has never made surplus. Monthly trade balance in last two years (Unit: USD 1 million) Source: Korea Customs Service The pharmaceutical industry analyzes the big leap in biosimilar export has played a significant role in breaking the record of pharmaceutical export and trade balance performance. In fact, the half-year report each submitted to the Financial Supervisory Service by Celltrion Healthcare ad Samsung Biologics found the two companies have generated export volume of 777.2 billion won and 380.5 billion won, respectively. Compared to last year same time, both companies have made historic records. Celltrion’s exports in Europe and the U.S. have been impressive. From early this year, the company started marketing Remsima SC in Europe, and their Truxima and Herzuma have started making revenue in the U.S. Remsima SC is the world’s first subcutaneous injection with infliximab substance. Samsung Biologics’ performance started to take off from the second half of last year, and its business entered a stable state. The comprehensive performance was boosted by the overall production capacity increased with the third manufacturing plant in full motion, and CMO sales leaned heavy on more highly priced products.
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- Who distributes Pfizer-Moderna vaccine in South Korea?
- by Kim, Jin-Gu Dec 17, 2020 06:12am
- Just as Pfizer has, Moderna is getting close to receive the U.S. Food and Drug Administration’s (FDA) emergency use authorization for its COVID-19 vaccine. Currently, the South Korean government is in negotiation with two companies to supply their vaccines in the country. The attention is focused on how the vaccines would be manufactured and distributed as the government promised to ink the vaccine supply contract for 10 million people from each company. Ultimately, Pfizer’s vaccine would likely to be manufactured in the vaccine manufacturing facility in Belgium and exported to South Korea via Pfizer Pharmaceutical Korea. The vaccine purchasing cost would be covered by the Korean government, but the import and distribution would be handled by Pfizer Pharmaceutical Korea. Moderna, on the other hand, does not own its manufacturing facility or a South Korean branch. The rumor has it that a Korean company could sign a deal with the company to distribute the vaccine. ◆SK Bioscience to manufacture and distribute AstraZeneca vaccine The government has decided to import COVID-19 vaccine doses for total 44 million people. Out of the total, the finalized contract secured doses for 10 million people each via COVAX Facility and AstraZeneca. The government is in negotiation for the rest of the doses for 24 million people with Pfizer (10 million), Moderna (10 million) and Janssen (4 million). SK Bioscience is to manufacture and distribute AstraZeneca With the finalized contract, AstraZeneca’s vaccine would be manufactured and distributed by SK Bioscience. Previously, the Korean government, AstraZeneca and SK Bioscience have signed a three-way contract for the COVID-19 vaccine. The contract states SK Bioscience would manufacture the vaccine when AstraZeneca succeeds in developing one. AstraZeneca has no other vaccine line up other than the COVID-19 vaccine. The company has to seek after manufacturing facility around the world to manufacture the product, and SK Bioscience was selected in the end for the Asian region. The vaccines manufactured by the Korean-based company would be supplied to other countries in Asian region that also made deals with AstraZeneca. However, the biggest issue is that the multinational company’s vaccine has not completed the Phase III trial. The supply can initiate only when the vaccine finishes its Phase III trial. And after it confirms the efficacy and safety, the company needs to undergo a procedure starting from approval application to the Ministry of Food and Drug Safety (MFDS) approval and the state authorization for shipping. AstraZeneca expects the vaccine would conclude the Phase III trial in early next year. The government’s announcement on the plan to begin the vaccination from March next year seems to have been influenced by the company’s news. ◆Inked a contract with CEPI, GC Pharma to supply through the Facility The vaccine doses for 10 million people contracted through COVAX Facility have not decided which product vaccine would be manufactured and supplied for how many doses. The COVAX Facility is an international cooperation project, created by the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance, to ensure fair distriution of COVID-19. So far, 180 countries have joined the effort. With the fund raised by the participating countries, COVAX Facility is currently funding nine vaccine developments, including the ones by Moderna, AstraZeneca, Novavax, Inovio, CureVac and GSK. From the list of the companies, Moderna has the vaccine within arm’s reach to commercialization. The U.S. FDA Advisory Committee is scheduled to convene a meeting on Dec. 17, and the emergency use authorization could be granted on Dec. 18 at earliest. The pharmaceutical companies that received the funding from COVAX Facility are responsible to supply vaccines to 180 member countries. When Moderna earns the FDA approval for the vaccine use, other COVAX member countries would also get access the vaccine. During the process, GC Pharma is getting the spotlight. GC Pharma has signed a contract with CEPI for the use of manufacturing facility in last October. When a company supported by CEPI successfully develops a COVID-19 vaccine, the Korean company can manufacture 500 million doses from its vaccine factory. The company already plans to manufacture CEPI-designated COVID-19 vaccines from March 2021 through May 2022. The company would use brings vaccine components to the factory to fill and finish the complete product. Some of these manufactured doses may be distributed throughout South Korea, but the government has not signed the contract completely, yet. If Moderna or other candidate company shakes hands with CEPI on manufacturing facility, GC Pharma would then sign an official contract with the companies. But as Moderna has not received the official green light, the detailed manufacturing volume has not even been set. ◆Pfizer vaccine for 10 million to be imported via Pfizer Pharmaceutical Korea Pfizer Pharmaceutical Korea is most likely to supply Pfizer’s vaccine for 10 million people. Pfizer owns vaccine manufacturing plants in Michigan and Belgium. The plants in Michigan are to supply vaccines in the U.S., and the supplies for other countries including Europe would be manufactured in Belgium. Similar to the novel influenza breakout in 2009, Pfizer Pharmaceutical Korea would import the supply manufactured in Belgium. Back then, the government signed a deal with Roche for the sales handling storage to distribution. As Pfizer is not funded by either COVAX Facility or CEPI, the company holds no responsibility to supply to any country without a contract. Currently, the Korean government is working on the settling the contract.
- Company
- Keytruda can be prescribed for TNBC patients in Korea
- by Eo, Yun-Ho Dec 17, 2020 06:11am
- It is expected to be able to prescribe Keytruda, an immune anticancer drug, to patients with triple-negative breast cancer (TNBC) in Korea. According to related industries, MSD Korea recently submitted an application for additional indications for the combination of chemotherapy in the first line therapy of metastatic TNBC of PD-1 inhibitor Keytruda (Pembrolizumab) to the MFDS. After approval by the US FDA, the approval process is rapidly progressing in Korea. Keytruda's effectiveness in TNBC patients was demonstrated in the KEYNOTE-355 study. In this study, Keytruda showed improvement in Progression Free Survival (PFS) and an objective response rate of 53% (17% for complete, 36% for partial) in the entire patient group including patients with poor prognosis who recurred rapidly for more than 6 months, suggesting the possibility of cure in metastatic TNBC with a high rate of complete remission. Through a sub-analysis that confirmed the therapeutic effects of TNBC's combination of various chemotherapy and Keytruda at the San Antonio Breast Cancer Symposium, SABCS 2020 recently, the PFS improvement effect was shown regardless of the type of chemotherapy. It means that various combinations of chemotherapy such as Paclitaxel, Albumin-binding Paclitaxel, Gemcitabine·Carboplatin can be used in combination therapy with immuno-cancer drugs. TNBC, which responds negatively to all receptors (Estrogen, Progesterone, HER2) among breast cancer, has been an unsolved challenge for a long time. Chemotherapy was the only treatment option for TNBC, and Roche's target anticancer drug Avastin (Bevacizumab) was the first in Korea to obtain indications, but it has remained as non reimbursed drug. However, PARP (poly ADP ribose polymerase) inhibitor Lynparza (Olaparib) was added as a target anticancer option, and Roche's PD-L1 inhibitor Tecentriq (Atezolizumab) was the first to be introduced as an immune anticancer agent. Roche submitted an application for benefits in Korea in October and is waiting for the HIRA's Cancer Disease Review Committee's appointment.
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- Pharmaceuticals' dilemma over the possibility of level 3
- by Kim, Jin-Gu Dec 17, 2020 06:11am
- While the government is considering level 3 of social distancing, the pharmaceutical industry is also taking countermeasures. Even if level 3 of social distancing are fully implemented, most of them maintain the flexible working system as they are now. However, internal discussions on the scope of essential manpower are in full swing in that it is an administrative order to work from home except for the mandatory manpower. ◆Executive order to work from home except for required manpower when upgrading to level 3 According to the Central Disease Control Headquarters on the 14th, as of midnight on that day, the number of COVID-19 confirmed cases was 718. It decreased by 312 from 1030 the previous day. The number of COVID-19 confirmed cases in Korea exceeded 1,000 on the 13th as the third pandemic began in earnest. The government expects the number of confirmed cases to increase to 1200 in the future. The government recognizes the current situation as the biggest crisis since the outbreak of COVID-19. As a final method, level 3 is also being considered. Level 3 of social distancing is upgraded when the weekly average number of confirmed patients is 800-1000 or more. President Moon Jae-in said at the Central Disaster and Safety Countermeasure Headquarters meeting urgently presided on the 13th, "If we can't break the spread now, we need to review level 3. If Central Disease Control Headquarters believes it is inevitable, then boldly decide to (upgrade)." The pharmaceutical industry is also tense in that an executive order is issued to allow private companies to work from home if the social distancing level is elevated. Looking at the government's step-by-step measures, in level 2.5, the recommendation to work from home for more than a third of the number of employees is reinforced to mandatory work from home outside of the required manpower. However, it is up to the company to decide how to set up the required manpower. The number of COVID-19 confirmed patients per day. With the recent surpassing 1,000, the possibility of level 3 is increasing (Source: Johns Hopkins) ◆Even now, only essential personnel are on the way to work The pharmaceutical industry is very nervous with government announcements. The whole society is in 'shutdown' situation. Officials on the front line are concentrating on preparing countermeasures while checking the government announcement in real time. However, they are contemplating what specific measures to take. Most pharmaceutical companies are already taking steps similar to level 3. Even now, when level 2.5 is being applied, the rest of the workforce is working from home, except for the required manpower, so there is little to do when the social distancing into three stages is upgraded. Accordingly, pharmaceutical companies are discussing the scope of mandatory manpower. If the required manpower was previously team leader and a few team members, when the social distancing is upgraded, it is reduced to only team leader. A representative of a domestic pharmaceutical company said, "The current company's official guidelines are Only essential personnel go to work, but in fact, the team is divided into two groups or three groups to go to work every other day. If it is upgraded to level 3, only the team leader goes to work. He expects the rest to go to work only in very urgent cases under the judgment of the team leader. Another domestic pharmaceutical company official said, "Before the implementation of level 2.5, we have been selectively working from home. Even if it is reinforced to level 3, it is not expected that the company will decide whether to go to work or stay at home according to the position or job group. Under the conditions, it is decided whether to work from home, but each team leader will select the required manpower based on a tighter standard." “We are preparing separate guidelines at the company. The overall direction is the same. We freely decide to go to work and home in consideration of personal circumstances and work environment. However, in case of upgrading to level 3, working from home is given priority.” If it is upgraded to level 3, most salespeople are expected to convert to telecommuting ◆Production workers are inevitable However, in the case of production workers, they are essential workers, so even if they are upgraded to level 3, it is impossible to work from home. another official from a domestic pharmaceutical company, said, "If the company is upgraded to level 3, all sales workers will be converted to telecommuting. Researchers will also participate in telecommuting, leaving only a small number of personnel." “In the case of production workers, it takes a month or two to restart even if the factory stops operating for one day. In the case of production workers, it will inevitably continue to work. However, measures such as changing from the current three shifts to two shifts are under discussion." Some say that even if it is upgraded to level 3, it will remain the same as the present. Mr. E, an official at a domestic pharmaceutical company, said, “It is already common to work from home. All sales workers are at home, and all employees in the rest of the field come to work. It is difficult to further reduce the required manpower.” Another domestic company official, Mr. F, said, "Officially, under the judgment of the manager, only essential personnel are instructed to go to work. However, almost all of the employees are present. Therefore, even if the level is raised to 3, the manager judges everyone as essential personnel. If so, nothing will change from now.”
- Company
- The CEOs of eight multinational companies were replaced
- by Eo, Yun-Ho Dec 16, 2020 02:08pm
- From the top left, CEOs of Oh Dong-wook, Kim Youn-hee, Choi Ho-jin, Kim So-eun, Kim Woo-gyu, Lee Hye-young, Kevin Peters, and Rob Kempton Eight multinational pharmaceutical companies have appointed new CEOs during this year On the 14th, Dailypharm collected the current status of CEOs of major multinational companies in Korea, including 31 Korea Global Pharmaceutical Industry Associations (KRPIA) (currently). As a result, 8 pharmaceutical companies replaced or appointed new CEOs. Although there were regular personnel executions due to the expiration of the term, there were also personnel measures due to separate issues such as merger and corporate division. The foreign head of the three pharmaceutical companies left. The KRPIA is represented by Dong-wook Oh, President of Pfizer Korea, instead of Avi BenShoshan, former CEO of MSD Korea. As of October, Galderma Korea appointed CEO Kim Youn-hee and changed the system to a Korean president again in about two years after Park Heung-beom resigned. Rene Wipperich, former CEO of Galderma Korea for two years from September 2018, moved to a Swiss subsidiary. Current status of CEOs of major multinational pharmaceutical companiesMerck, which has maintained a foreign system since the inauguration of the Korean subsidiary, appointed Kim Woo-gyu in September. He received his Ph.D from the University of Delaware in the United States and was appointed as a Korean subsidiary after serving as the head of the Performance Materials division at the German headquarters of the Merck Group in 1997. Ono Pharma Korea, which has been replaced in about a year, continues the Korean system by appointing former Vice President Choi Ho-jin as CEO along with the retirement of former CEO Min-yeol Yang. Ono Pharma Korea was managed by former CEO Takashi Kishi, who was appointed former CEO Yang. There is also news of the appointment of the head of a new corporation to be launched due to the division of the corporation. Viatris, which had been maintained under the name of Pfizer Upjohn, which was created through the corporate division of Pfizer, was officially launched and appointed Lee Hye-young as the first CEO. CEO Lee was in charge of Pfizer's patent expiration division. In the case of MSD, the official term of office began next year and was not reflected in the count, but Organon, which is spun off from MSD, was also appointed by Kim So-eun as the head of the first Korean subsidiary. Executive Director Kim will lead Organon from February next year. MSD and GSK's Korean subsidiaries continue to be foreign CEOs. MSD appoints Kevin Peters from a Thai subsidiary, and GSK's new president, Rob Kempton, takes over as Julien Samson moves to the headquarters. Mundipharma appointed Choi Heon and Astellas appointed Weber Markus as the new president. The proportion of Koreans among CEOs of multinational companies was 70%, a slight increase from the previous year (66%). In addition, the proportion of female CEOs fell 5% to 25%.
- Company
- Prevymis by MSD is prescribed at Big 5 General Hospitals
- by Eo, Yun-Ho Dec 16, 2020 06:14am
- Prevymis, which is used to prevent cytomegalovirus infection in patients with allogeneic hematopoietic stem cell transplantation, can be prescribed at general hospitals. According to related industries, Prevymis (Letermovir), a prophylactic treatment for cytomegalo virus (CMV) infection in patients with allogeneic hematopoietic stem cell transplantation, is known as Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, Asan Medical Center, and Seoul St. Mary's Hospital. It passed the drug commitee (DC) of the general hospitals. Prevymis has been listed since last October, being evaluated as clinically useful and cost-effective than conventional non-prevention cases. As prescription codes were created in major hospitals, Prevymis will be precribed in earnest in the future. Allogeneic hematopoietic stem cell transplantation is essential for the cure of severe blood cancer patients such as acute myelogenous leukemia and acute lymphocytic leukemia. As a policy to strengthen health insurance coverage, the government changed the age limit for recognizing hematopoietic stem cell transplants in 2019 from under 65 years old to under 70 years old. Even if the tissue-appropriate antigens in the transplant's family are only partially matched, efforts have been made to revitalize transplantation and reduce costs by recognizing the first allograft as a benefit in the absence of a suitable donor. When cytomegalovirus (CMV) is reactivated in patients with hematopoietic stem cell transplantation, diseases such as pneumonia, hepatitis, myocarditis, gastroenteritis, and encephalitis develop. Even low levels of CMV in the blood have an effect on increased mortality. In the case of hematopoietic stem cell transplantation patients with CMV infection, the mortality rate during initial hospitalization increased by 3.5 times compared to those without infection, and the risk of death was reported to be 2.6 times higher in patients with CMV viremia at the initial stage of transplantation (within 60 days). However, the current CMV treatment of allogeneic hematopoietic stem cell transplant patients relies on pre-emptive treatment of antiviral drugs when the virus concentration in the blood exceeds a certain level. Prevymis has been clinically proven to inhibit CMV reactivation and reduce mortality. In addition, no adverse reactions related to myelotoxicity and nephrotoxicity occurred. In the 2019 guidelines of the National Comprehensive Cancer Network (NCCN) and the European Conference on Infections on Leukemia (ECIL), Prevymis is a prophylactic drug for allogeneic hematopoietic stem cell transplant patients with CMV seropositivity.
- Company
- AbbVie expands autoimmune disease drug line-up fast
- by Eo, Yun-Ho Dec 15, 2020 06:04am
- AbbVie is quickly lining up next cash cows after Humira. Especially, the company’s speed of new drug reimbursement listing for the South Korean market has impressed the industry. The multinational company only took about six months and five months for an interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) and a Janus kinase (JAK) inhibitor Rinvoq (upadacitinib), respectively, from the approval by the Ministry of Food and Drug Safety (MFDS) to reimbursement listing. Skyrizi and Rinvoq were green lit late last year and June, and listed in June and November, respectively. As two drugs are third to fourth drugs to be approved in their respective classes, AbbVie fully utilized the approval-listing linkage system, and accepted the weighted average pricing of other alternative options to expedite the listing process. Also when the company launched the hepatitis type C treatments Mavyret (glecaprevir-pibrentasvir), AbbVie targeted the listing first and started expanding the market presence fast. Both an IL inhibitor and a JAK inhibitor are the most anticipated treatment option for autoimmune diseases since the release of a tumor necrosis factor (TNF)-α inhibitor. While Humira (adalimumab) is leading the particular market, AbbVie seems to have sped up the listing process to minimize the handicap in follow-on drug. The future competition in the market is expected to intensify regardless of the sluggish growth in existing options with slightly different indications the two drugs have. An industry insider commented, “Surely, the quick judgment call by AbbVie Korea was impressive. With the complication of being a follow-on drug, the company could have taken more time to set the strategy based on the differences in indications, detailed mechanism and clinical protocol.” Meanwhile, Skyrizi is indicated to treat adults with moderate to severe plague psoriasis, who need UVB phototherapy or systematic therapy (including biologic therapy). The UltIMMa-1 and UltIMMa-2 studies, which the approval was based on, found patients using Skyrizi have significantly improved their skin condition at week 16. And most of the patients—82 percent and 81 percent—reached Psoriasis Area and Severity Index (PASI) 90, and many of the patients—56 percent and 60 percent—had completely improved skin after a year (52 weeks). Rinvoq has confirmed its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY). The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira.
- Company
- Evenity, customized for patients with high risk of fracture
- by Dec 15, 2020 06:03am
- As Amgen's new osteoporosis treatment, Evenity (Romosozumab) was applied from this month, it could be used more by patients. In particular, Evenity, which has proven its strong efficacy in patients with high risk of fracture, may be useful. On the 10th, Amgen held an online meeting to commemorate the launch of Evenity insurance benefits, and announced Evenity's treatment strategy in the ultra-high risk group for osteoporosis fractures. Amgen's new osteoporosis treatment, Evenity (Romosozumab) was approved in May of last year as a treatment for postmenopausal women with osteoporosis at high fracture risk and for increasing bone density in men with osteoporosis at high risk of fracture. Benefits for Evenity have been applied since the 1st. This is when all are satisfied among patients who do not have an effect on or cannot use existing bisphosphonates ▲postmenopausal women over 65 years old ▲Bone density test result measured by dual energy radiation absorption measurement at the central bone T-score -2.5 SD or less ▲Among conditions with two or more osteoporotic fractures. Patients who satisfy this condition can receive benefits once a month, up to one year. Professor Kim Deok-yoon of the Department of Endocrinology at Kyunghee University Hospital announced on this day 'the latest knowledge of osteoporotic fracture treatment and customized treatment strategies for ultra-high-risk patients'. He said, "One in three hip fracture patients cannot walk without help for two years, and one in four dies within 12 months." Kim Deok-yoon, Professor of Endocrinology and Internal Medicine, Kyung Hee University Hospital For this reason, the latest guidelines recommend that patients in these ultra-high risk groups reduce the risk of fracture through strong drug treatment. Evenity can play a useful role as it has the effect of inhibiting bone resorption in addition to existing bone formation promoting agents. If the bone density is the same or improved after 1 year of treatment with Evenity, treatment can be continued with another bone resorption inhibitor. He said, "It is important to lower the risk of fracture with strong drugs such as Evenity from the beginning of treatment for the ultra-high-risk group of osteoporosis fracture. From this month, it is expected that customized treatment for the ultra-high-risk group will be possible with the application of Evenity." He added, "It is the norm to use bone formation promoting agents first in the treatment of patients in ultra-high-risk patients, and then follow-up treatment with bone resorption inhibitors." Amgen believes that Denosumab could serve as a follow-up treatment after Evenity. He agreed that "Romosozumab-Denosumab treatment will be the best combination. In fact, this combination should be used to quickly get out of the risk of fracture." However, he was disappointed by the limited benefit standards. He said that Evenity was considered a very useful drug for patients with super-risk patients, and since last May, he thought that even a non-reimbursed drug should be used and it would be very welcome that Evenity became a reimbursed drug this time. Sang-yoon Kim, managing director of marketing at Amgen Korea's General Medison Division, said, "We will try to establish Evenity as a standard treatment for people at high risk of fractures. And, we will work on long-term osteoporosis treatment strategies ranging from Evenity, which is effective for strong initial treatment to Prolia, suitable for continuous treatment in Korea. I will actively seek out with the medical staff.”
