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- 2025-12-26 12:27:07
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- Big 5 Hospitals actively prepare CAR-T ‘Kymria' centers
- by Eo, Yun-Ho Apr 22, 2021 05:53am
- The ‘Big-5’ tertiary hospitals in Korea are working fast to introduce the first CAR-T therapy ‘Kymriah’ to their institutions. According to industry officials, among the Big-5s, Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, and Severance Hospital are in the process of acquiring the ‘human cell management business approval’ from the Ministry of Food and Drug Safety, and Samsung Medical Center (SMC) already obtained the approval. In Seoul National University Hospital, Kymriah (tisagenlecleucel) passed the drug committee (DC) review in April, and the drug is also expected to land in Samsung Medical Center in May. Kymriah developer Novartis has allowed general hospitals to be paid for the ancillary costs by establishing Kymriah centers in their institutions. SMC and SNUH will open their Kymriah centers in May, and other tertiary hospitals are expected to follow. To establish the center, hospitals are first required to receive a permit for the human cell management business under the newly implemented ‘Advance Regernative Bio Act.’ Kymriah is the first CAR-T therapy and the most expensive drug in Korea up to date. The drug is indicated for adult patients with diffuse large B cell lymphoma (DLBCL) and young adult and pediatric patients with acute lymphoblastic leukemia (ALL). Both indications are for late-stage patients that are in relapse post-transplant or in second or later relapse after two or more lines of therapy. CAR-T therapy takes a different approach in its method of treatment. Unlike conventional drugs that are produced as finished products, for CAR-T, the hospital first collects T cells from the patient's white blood cells, then freezes and sends them to a manufacturing facility. At the facility, the T cells are genetically engineered to express the chimeric antigen receptors (CARs) that allow the T cells to recognize tumor cells, cultivated, then sent back to the hospital. In other words, after the hospital sends the raw material (patient’s T cells) to the company, the company makes the finished ‘Kymriah’ product with the raw material and sends it back to the hospital. The hospital maximizes the effect of Kymriah by using lymphodepleting chemotherapy to reduce the white blood cell count in advance. After 4-5 weeks, the processes are all complete, and Kymriah is finally infused into the patient. “Kymriah is an innovative, personalized treatment for each patient with a new mechanism of action that allows the patient to complete treatment with just ‘one shot.' It is a treatment that has never been seen in the history of anticancer treatment.,” said Sung-soo Yoon, professor of Hemato-Oncology at the Seoul National University Hospital. “Patients with relapsed∙refractory DLBCL who failed two or more lines of treatment or transplant that are left with a life expectancy of only three to six months can reach complete remission after a single treatment and increase their rate of survival.” “Relapsed∙refractory ALL patients are very rare in Korea, however, these few young patients that are diagnosed every year are in the fight for their lives,” Said Chuhl Joo Lyu, professor of pediatric Hematology-Oncology at Severance Hospital said. “The government, pharmaceutical company, and the medical community should work together to create an environment for these young patients to enable timely treatment with Kymriah.”
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- Tremfya reimbursement approved for palmoplantar pustulosis
- by Apr 22, 2021 05:53am
- Janssen’s interlukin-23 (IL-23) inhibitor ‘Tremfya (guselkumab)’ will be reimbursed from May 1st for the treatment of palmoplantar pustulosis. The reimbursement will apply to patients over the age of 18 years who were diagnosed with moderate to severe palmoplantar pustulosis that has lasted for more than 6 months that ▲ have a Palmoplantar Pustulosis Area and Severity Index (PPPASI) score of 12 or higher and have no response to Acitretin for at least 3 months or had to discontinue treatment due to side effects(medical report required); or ▲have a PPPASI score of 12 or higher and show no response to phototherapy for at least three months or had to discontinue treatment due to side effects; Tremfya is the first and only biological treatment in Korea available for patients with palmoplantar pustulosis. In a Phase III clinical trial, the patient group treated with Tremfya significantly lowered their PPPASI score compared to the placebo group. At 52 weeks, patients in the Tremfya treatment group still showed continuous improvement, and achieved a PPPASI-50(≥50% improvement) and PPPASI-75(≥75% improvement) response of 83.3% and 55.6%, respectively. “With the reimbursement approval, we are pleased to be able to provide a new treatment option to palmoplantar pustulosis patients in Korea," said TaeYun Jung, Director of the Immunology Business Unit at Janssen. "Starting with the TNF-a blocker Remicade to Stelara, Janssen has been in the forefront of providing new treatment options for patients suffering from psoriasis. We will continue to spare no effort for our patients that suffer from immune disorders, including psoriatic diseases.” Palmoplantar pustulosis is a chronic inflammatory skin disorder that presents as sterile pustules or red patches on one's palms and soles.
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- Sanofi to sell Hanmi's AmosartanQ' in Russia
- by An, Kyung-Jin Apr 22, 2021 05:53am
- AmosartanQHanmi's IMD AmosartanQ will be launched in the Russian market through Sanofi. Hanmi announced on the 20th that Sanofi has obtained marketing approval from the MOH for AmosartanQ under the product name Tristanium. AmosartanQ is a combination drug that combines Amlodipine Camsylate, a component for treating hypertension of CCB, and Losartan potassium, a component for treating hypertension of ARB, and Rosuvastatin Calcium, a component for treating hyperlipidemia. Sanofi is in charge of local licensing, sales marketing, and sales in Russia by receiving the right to use exclusive Russian license materials for AmosartanQ from Hanmi. This time, with the marketing approval, it is planning to establish a sales marketing strategy for AmosartanQ and launch it officially. Hanmi produces finished products at the Paltan Smart Plant in Gyeonggi Province and exports them to Russia. According to Hanmi, Russia is the second largest pharmaceutical market in Europe. In particular, the hypertension treatment market is evaluated for its high potential growth rate. According to the European Society of Cardiology, the incidence of hypertension in Russia is as high as 4 out of every 10 people, but only about 20% are actively treated. AmosartanQ (Amlodipine, Losartan, and Rosuvastatin) is ganerating market sales of about ₩400 billion ($3.9 billion) in Russia. Amosartan (Amlodipine and Losartan) has been on sale in Russia with Sanofi since 2017. It has grown at an annual average rate of 21% over the past four years. Hanmi expects that AmosartanQ will receive a positive response in the Russian market as well. AmosartanQ is an important product of the Amosartan Family, which records annual prescription sales of ₩100 billion in Korea," said Jongsoo Woo, CEO of Hanmi. He said, "Starting with Russia, we will do our best to accelerate entry into the global market."
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- Schingles is expected to be released in the end of the year
- by Apr 21, 2021 05:50am
- GSK's Schingles, which boasts the highest efficacy among the existing shingles vaccines, is expected to receive product approval at the end of the year as soon as possible. When Schingles is released in Korea, fierce competition is expected with Zostavax and Sky Zoster. According to the pharmaceutical industry on the 21st, GSK applied for Schingles item approval from the MFDS in January and is currently undergoing review. Approval is expected within the year, considering the period of time it normally takes for a permit review. It is expected that it will be able to obtain a permit at the latest early next year. Schingles was first approved in the United States in October 2017 and in Europe and Japan. In the US, the market share reached 98% a year after the launch of Schingles. Worldwide sales amounted to ￦1.1 trillion in 2018, ￦2.5 trillion in 2019, and ￦3 trillion in 2020. The defense rate is stronger than other products. In a clinical trial involving adults 50 years and older (ZOE-50), Schingles demonstrated a 97.2% ERA at 3.2 years of follow-up. Those over 70 years old (ZOE-70) showed 89.8% efficacy after 3.7 years of follow-up. The conventional vaccine, MSD's Zostavax, showed 51% protection in patients over 50 years of age. It was 41% of those over 70 years old. SK Bioscience's Sky Zoster has no known ERA figures. With a non-inferiority test against Zostavax, it can be assumed that the ERA is similar. Schingles is an inactivated vaccine, unlike the live attenuated vaccine Zostavax, and is particularly recommended for patients with weakened immunity. Accordingly, the CDC recommended Schingles first over existing products as a shingles vaccine for adults over 50 years of age. People who had previously been vaccinated with Zostavax also recommended Schingles re-vaccination. Schingles has two doses and is a bit more expensive. Zostavax and Sky Zoster are given a single dose, whereas Schingles requires two doses at intervals of 2 to 6 months. The price is also expected to be higher than the two products. Concerns over Schingles' supply shortages are reported to be largely resolved. At the time of launch, there was a shortage of supply due to failure to keep up with demand. Accordingly, GSK is continuously expanding its production capacity and increasing its supply. Currently, the domestic shingles vaccine market includes Zostavax and Sky Zoster. Originally, Zostavax was the only one, but with the launch of Sky Zoster in October 2017, it quickly eroded the market. Market sales of Zostavax and Sky Zoster based on IQVIA last year were ￦43.2 billion and ￦29.1 billion, respectively. Competition between the three products will be fierce from next year when Schingles sales are in full swing.
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- Lynparza tablet to be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Apr 21, 2021 05:49am
- The tablet formulation of the anticancer drug ‘Lynparza’ can now be prescribed at the Big-5 tertiary hospitals. Industry sources reported that AstraZeneca’s poly ADP ribose polymerase (PARP) inhibitor Lynparza (olaparib) passed the review of drug committees (DC) in the five major hospitals, the ‘Big-5s,’ which include the Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, and Severance Hospital. With Severance Hospital’s DC giving the last nod, Lynparza has now landed in all five hospitals as well as 25 other medical institutions nationwide. As the company received approval from HIRA's Drug Review Evaluation Committee (DREC) to reimburse Lynparza for the ‘first- and second-line maintenance treatment of patients with BRCA-mutated ovarian cancer,’ prescriptions are expected to be made soon after being listed for reimbursement. The company had submitted an application to expand Lynparza tablet's reimbursement to ▲first-line maintenance treatment for patients with BRCA-mutated advanced ovarian cancer; ▲second-line or higher maintenance monotherapy for patients with recurrent platinum-sensitive advanced epithelial ovarian cancer; and ▲HER-2 negative metastatic breast cancer; however, reimbursement for second-line treatment of mBRCA-negative ovarian cancer and breast cancer patients were rejected in the listing process. The addition of the tablet formulation also signifies an improvement in the convenience of oral administration for patients. In the SOLO-2 trial, which investigated the efficacy of the tablet formulation of Lynparza, the 300mg of the tablet formulation taken twice a day met the primary efficacy endpoint. The recommended dose of the Lynparza tablet is two 150mg tablets (300 mg) taken orally twice daily, while the dose for the Lynparza capsule is eight 50mg capsules (400mg) taken orally twice daily. The total number of pills to take is reduced from 16 to 4 per day with the tablet formulation. Lynparza was listed for ovarian cancer in October 2017 as an expenditure cap type under the Risk Sharing Agreement (RSA) through the PE exemption policy. However, the coverage only applied for its use as maintenance therapy for 15 months following chemotherapy. Due to the period limit, cases of patients being discontinued reimbursement started to arise from January 2019. To resolve the issue, the government and AstraZeneca discussed expanding the reimbursement and lifted the period limit set on the drug.
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- Generics for Eliquis are sold out
- by Apr 20, 2021 09:13am
- The production and sales of generics that lost Eliquis(Apixaban)' patent dispute were halted. According to the drug distribution industry on the 16th, generic for Eliquis companies stopped producing and selling items at once after the Supreme Court ruling. There is some inventory that has been passed to wholesalers. Generics for Eliquis have been released since June 2019 ▲Chong Kun Dang's Liquisia ▲Yuhan’s Yuhan Apixaban ▲Samjin's Elxaban ▲Hanmi’s Apixban ▲Yooyoung’s Yupix, and ▲Huons’ Apiquis. The Supreme Court overturned the court case on the 8th and sided with the patent holder, BMS. Distribution was stopped in preparation for compensation for damages in the final judgment. The Supreme Court overturned the court case on the 8th and turned to the side of the patentee, BMS. Unless a new allegation is raised, the judgment of the superior court is usually followed. Accordingly, domestic companies began to stop sales in preparation for a lawsuit for damages that BMS will file. They sent an official letter to the retailer, saying, ``We will stop production and sales after it is sentenced according to the decision to abolish the court's judgment in the court below. Most of the pharmacy-only online malls were sold out, except for some wholesalers that had left stock. Representatively, Chong Kun Dang’s Liquisia 2.5mg is out of stock, and only 8 of Liquisia 5mg are in stock. Since the amount of damages is determined in proportion to the amount of sales, it seems that generic companies have quickly stopped selling. Generic for Eliquis market has grown significantly over the past year. The generic market, which had sales of \1.2 billion in 2019, expanded 622% to \8.3 billion in 2020. This contrasts with the 2.6% decline in sales of original Eliquis. However, if the Supreme Court verdicts at the remand of revocation, the generic can only be released after September 2024. Due to the Supreme Court ruling, generic drugs are being sold out at online malls dedicated to pharmacies
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- SG&A ratio fell in 3 out of 4 MNCs...a COVID-19 Impact?
- by An, Kyung-Jin Apr 20, 2021 06:03am
- Korean subsidiaries of multinational pharmaceutical companies have lowered their selling, general & administrative (SG&A) to sales ratio last year due to the prolonged COVID-19 crisis. Analysts predict that the cost-cutting measure was made in response to the disruptions in face-to-face sales and marketing activities caused by the pandemic. According to the Financial Supervisory Service (FSS) on the 19th, the SG&A expense of 34 major subsidiaries of multinational pharmaceutical companies in Korea last year amounted to 1.7 trillion won, a 0.8% increase from the previous year. The result is based on audit reports of the 34 subsidiaries that submitted reports to FSS. 31 companies that close accounts in December - Sanofi-Aventis Korea, Novartis Korea, AstraZeneca Korea, GlaxoSmithKline Korea, Bayer Korea, Roche Korea, Zuellig Pharma Korea, Baxter Korea, Janssen Korea, Merck, Korea Otsuka Pharmaceutical, BMS Korea Pharmaceutical, Amgen Korea, Boehringer Ingelheim Korea, GSK Consumer Healthcare Korea, Lilly Korea, AbbVie Korea, Mundipharma Korea, Menarini Korea, Novo Nordisk, Fresenius Medical Care Korea, Galderma Korea, Sanofi Pasteur, Alcon Korea, Kyowa Kirin Korea, Lundbeck Korea, Ferring Korea, Teva-Handok, UCB Korea, Guerbet Korea, Leo Pharma - as well as Servier Korea (closes account in September), Pfizer Korea · Viatris Korea (closes account in November) were included for analysis. Despite the increase in the total amount of SG&A expenses, The SG&A to sales ratio of the companies had declined 1.9% points from the previous year’s 23.6% to mark 21.7%. At the same time, sales of the 34 companies have increased 9.6%. The SG&A to sale ratio declined as the SG&A expense of the companies did not increase as much as their sales. 15 of the 34 companies reduced their SG&A expense compared to the previous year. Alcon Korea's SG&A expense was 17.4 billion won last year, which was 71.3% lower than the previous year. During the same period, the company's sales revenue increased 22.1% from 165 billion won to 201.4 billion won, decreasing the SG&A to sales ratio by as much as 28.0% points. Guerbet Korea spent 8.7 billion won as SG&A expense last year. Guerbet Korea’s SG&A to sales ratio last year was 21.8%. Although its SG&A expense fell greatly, its sales also fell by 6.9%, resulting in a decrease in SG&A to sales ratio of only 2.4% points. Merck Korea and Teva-Handok also cut costs by reducing their SG&A expense by over 15%. 19 companies, which accounts for over half of the surveyed companies, increased their SG&A expense. SG&A expense of Lilly Korea, GSK Healthcare Korea, Leo Pharma, BMS Korea Pharmaceutical, Sanofi-Aventis Korea, Abbvie Korea, Roche Korea, Pfizer Korea, and Amgen Korea increased over 5% compared to the previous year. Viatris Korea, which officially launched last November, reported its SG&A expense as 72.5 billion won. The amount is an aggregate of its performance from December 2019 to November of last year. However, as the SG&A expense written for the previous year - 39.9 billion won - was expense spent from May to November 2019, the change in SG&A to sales ratio (81.5%) cannot be considered significant. 25 of the 34 companies showed a reduced SG&A to sales ratio. This means 3 out of 4 MNC companies lowered their SG&A to sales ratio. Amgen Korea is known to have a relatively higher SG&A to sales ratio in the industry. Until 2019, its SG&A to sales ratio was 59.9%, however, the ratio fell to 41.6% last year. As its sales revenue increased by 51.6% but its SG&A expense only increased by 5.4%, the overall SG&A to sales ratio fell 18.2% points. Merck Korea reduced SG&A expenses to 15.9% while increasing sales revenue by 20.9%. As a result, its SG&A to sales ratio fell 8.0% points from 26.2% to 18.2%. In companies like Galderma Korea and GSK Consumer Healthcare Korea, their SG&A to sales ratio decreased because their sales growth exceeded their SG&A expense. Galderma Korea had increased its SG&A expense last year by 1.9% from the previous year to mark 26.2 billion won, however, as its sales revenue grew 16.6%, its SG&A to sales ratio fell 6.7% points. For GSK Consumer Healthcare Korea, although its SG&A expense increased 13.4%, its sales revenue increased by 33.5%, resulting in a 6.2% point decrease in its SG&A to sales ratio. The SG&A to sales ratio varies greatly from company to company. Menarini Korea’s SG&A to sales ratio decreased by 1.5% point from the previous year, however, its ratio still exceeded half of its sales revenue. On the other hand, Zuellig Pharma Korea and Alcon Korea’s SG&A to sales ratio fell short of 10%.
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- Rx drug market recovers after flu season
- by Chon, Seung-Hyun Apr 20, 2021 06:02am
- The outpatient prescription drug market, which was slow in winter, is showing a recovery trend. Since the end of last year, the total prescription drug volume has been on a decline compared to the previous year, but in March it turned to an upward trend. It is analyzed that COVID-19 showed sluggishness due to a sharp decline in infectious disease patients due to the prolonged aftermath of the prolonged aftermath, but rebounded at the end of the flu season. According to the drug research institute UBIST on the 18th, the total outpatient prescription amount in the first quarter of the year was ₩3.5697 trillion, down 3.6% from the same period last year. Compared to the first quarter of 2019, it also decreased by 0.9%. The prescription size has increased every year, but this year has decreased. The prescription size in the first quarter of last year was ₩3.701 trillion, an increase of 2.7% from the previous year. In the first quarter of 2018 and 2019, prescriptions rose 8.9% and 5.5%, respectively, compared to the previous year. This is the aftermath of the sluggish prescriptions in January and February. The prescription size in January was ₩1,166.6 billion, down 7.0% from the previous year, and 5.6% in February compared to the same period last year. Monthly outpatient prescription amount trend (Unit: ₩100 million, Source: UBIST) However, the prescription performance in March was ₩1.253.7 trillion, up 1.9% from the previous year. Since December of last year, the total prescription drug volume has declined compared to the previous year for three consecutive months, and then turned to an upward trend in April. The sluggish prescription market in January and February was largely attributed to the prolonged COVID-19. Since the spread of COVID-19, it is highly likely that the incidence of infectious diseases has greatly decreased due to reinforced personal hygiene management such as hand washing and wearing a mask, leading to a decrease in visits to medical institutions. Since the end of last year, no flu pandemic warning has been issued this winter. According to the KCDA, the number of suspected flu patients per 1,000 outpatients during the 1st to 8th week of this year is 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, etc. Compared to 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5 outpatients per 1,000 outpatients during the 1st to 8th week of last year, there have been few recent flu cases. Since the end of last year, it is possible that visits to medical institutions have further decreased as the social distancing stage has been elevated due to the rapid increase in the number of COVID-19 confirmed patients. As more than 300 confirmed cases occurred from November 18 last year, the government raised the social distancing from November 24 to the second stage from the previous 1.5 stage. From then on, only packaging and delivery were allowed for cafes regardless of business hours, and only packaging and delivery were allowed after 9 pm for restaurants. Nevertheless, as the number of COVID-19 confirmed rapidly increased, the government raised the social distance in the metropolitan area to 2.5 steps from December 8 last year. Accordingly, in the metropolitan area, the operation of singing practice centers and indoor sports facilities in addition to the existing five types of entertainment facilities such as entertainment bars was additionally suspended. Shops, marts, department stores, movie theaters, PC cafes, and other facilities that are closely related to life must also close after 9 pm. Despite the rise in social distancing, the number of COVID-19 confirmed exceeding 1,000 and hitting a daily high, the Seoul Metropolitan Government implemented a super-precipitation measure that banned ``private gatherings with more than 5 people'' from December 23 last year, and such measures have been taken across the country since. Was applied to spread. Since last February, the social distancing step in the metropolitan area has been eased to two stages, but strengthened distancing measures are being implemented, such as “private gatherings for more than 5 people” are still banned. However, as the flu season ended in March, it is analyzed that the growth rate of the previous year has recovered. The number of suspected flu patients per 1,000 outpatients during the 9th to 13th week of this year was 1-2, similar to that of January and February. There is no significant difference from the 9th to 13th week of last year. Last year, it recorded 6.3 in the 9th week, but as the flu season ended, it decreased to 3.9 in the 10th week, 2.9 in the 11th week, 3.2 in the 12th week, and 2.8 in the 13th week. The industry diagnoses that the prolonged COVID-19 will inevitably hurt the prescription market for drugs used by flu or cold patients. However, as the use of medicines continues to increase due to the increase in the elderly population and the number of chronic diseases, the overall prescription market is expected to show an increase at the level of previous years. Although social distancing is still in place, it is observed that unlike the tourism and cultural industries that fell into extreme crises after COVID-19 outbreak, the pharmaceutical industry is affected by the demands of patients rather than the external environment, so it is difficult to lead to a sudden downturn.
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- Domestic Sputnik V CMO meets with MOHW for discussions
- by Kim, Jin-Gu Apr 20, 2021 06:02am
- Photo of Sputnik V With the possibility of using ‘Sputnik V' rising in Korea, various industry sources have confirmed that a Korean CMO of this Russian vaccine has had a meeting with Korea's Ministry of Health and Welfare (MOHW). According to industry officials, one of the companies that signed a CMO deal for Sputnik V has recently had a meeting with an official from the Vaccine Procurement Task Force at the MOHW Sejong Office. The meeting was held at the request of the MOHW, during which the CMO company briefly explained its production volume, schedule, and agreement process for Sputnik V. Future meetings between the company and MOHW have not been scheduled yet. An industry official said, "A director-level personnel of the pan-government vaccine procurement task force and one of the CMO companies of Sputnik V has recently had a meeting at the MOHW Sejong Office. During the meeting, the MOHW official looked over the basics of the CMO deal." On this, an official from the CMO company said, "It is true that a meeting was held. At the meeting, the MOHW simply verified the progress of the CMO deal, and nothing else was discussed. However, we cannot disclose any more specifics about the meeting." Recently, the possibility of using Sputnik V in Korea has been rising due to the global shortage in vaccine supply and the issue of blood clots in AstraZeneca and Janssen vaccines. The demand to introduce a new vaccine to Korea has never been stronger. Based on the same idea, the industry speculates that the meeting is the government's attempt to get a grasp of the present state of Sputnik V under the premise of introducing the vaccine to Korea. However, several steps are required for the government to introduce Sputnik V to Korea. First, the government needs to make a deal with the Russian Direct Investment Fund (RDIF). Like any other vaccines, the amount and schedule of the vaccines should be negotiated with the supplier. Also, a formal approval by the MFDS is required. The key to whether Sputnik V will be approved by MFDS may partially depend on the European Medicines Agency (EMA) decision. EMA is currently conducting a formal review of Sputnik V. The results are expected to be announced in May at best. If EMA approves Sputnik V, this may also speed up the process of introducing the vaccine to Korea. In Korea, the Hankook Korus Consortium and Huons Global Consortium have each signed a CMO agreement for Sputnik V. Under the agreement, the Hankook Korus Consortium will be producing 500 million doses and Huons Global Consortium will be producing 100 million doses. The consortia have already completed the transfer of technology from Russia for the production of Sputnik V. Mass production of the vaccine will become possible as soon as the production facilities are completed. Another industry official said, “If the government wishes to officially introduce Sputnik V to Korea, they have to first negotiate the terms with RDIF, as it has made the CMO agreement with the domestic companies. With the possibility of introducing Sputnik V rising in Korea, it seems that the government trying to get a grasp of the current state of affairs through working-level meetings." Sputnik V is a COVID-19 vaccine developed by Russia. Like AstraZeneca and Janssen vaccines, it is a viral-vector vaccine. Earlier this year, the vaccine was found to be 91.6% effective against COVID-19 according to a Phase III clinical trial results published in the Lancet.
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- Hemophilia B tx, Benefix, took the lead with weekly therapy
- by Apr 20, 2021 06:02am
- Pfizer Korea's Benefix (nonacog alfa)', which has been used for the treatment of hemophilia B patients in Korea for 15 years, has taken the lead as a once-a-week prophylaxis. The strategy for treating hemophilia has now become routine prophylactic therapy. The World Federation of Hemophilia recommended prophylaxis as standard treatment in its guidelines revised last year. In the past, the concept of prophylaxis was also aimed at preventing simple bleeding, but now, the goal is to lead a similar life to the general public and achieve a quality of life. In February, Benefix added an indication of daily prophylaxis with a weekly dosage. What was previously administered 2-3 times a week can now be administered only once a week. As a result of clinical studies, once-a-week prophylaxis reduced the annual bleeding rate to 94% compared to supplementary therapy. There was no significant difference in the annual bleeding incidence between the once-weekly prophylaxis and the twice-weekly prophylaxis. A similar effect can be obtained by administering Benefix 100IU/kg once a week instead of Benefix 50IU/kg twice a week. From the patient's point of view, fewer visits to the hospital can increase compliance and lower the risk of infection. In particular, once a week prophylaxis is most recommended for children under 6 years of age, where it is difficult to secure medical staff through intravenous infusion. In celebration of 'World Hemophilia Day (April 17)', Pfizer Korea held an online press conference on the 15th of 'The Present and Future of Hemophilia Type B Treatment Through Benefix' once-a-week prophylaxis. At the meeting, Professor Eun-jin Choi of Catholic University of Daegu Hospital said, "About half of patients with hemophilia B in Catholic University of Daegu Hospital are receiving Benefix once a week." Pfizer Korea's 'Benefix (nonacog alfa)', which has been used for the treatment of hemophilia B patients in Korea for 15 years, has taken the lead as a once-a-week prophylaxis. With the new indication, Benefix will be able to extend the range of half-life extension formulations. Benefix is a factor 9 standard half-life treatment. With the release of a half-life extension formulation, the relatively large number of doses is a disadvantage. For example, the half-life extension drug Alprolix 50IU/kg is administered once a week, and Alprolix 100IU/kg is administered once every two weeks, which is less frequent than Benefix twice a week. Benefix also expanded its area as weekly therapy became possible and occupied the first place in the hemophilia B market. Professor Choi said, "With the development of half-life extension drugs, drugs that fit once every two weeks and once every three weeks are emerging, depending on the patient's lifestyle. In some cases, the peak level is considered more important than the lowest coagulation factor activity level." If a patient wants to exercise such as soccer, he needs more than a certain percentage of the coagulation factor that the patient has, but if a patient has a peak level and shows low activity for 2 to 3 weeks (half-life extension drugs), it may not be suitable for that patient." She explained. There is no difference in the total dose for the twice-weekly or once-weekly therapy. Professor Choi said, "The current benefit is recognized as 30~40 IU, and if there is joint bleeding, it is possible up to 50 IU twice a week. Since there is no case written, 100 IU once a week is expected to be sufficient.”
