- LOGIN
- MemberShip
- 2026-05-18 13:59:03
- Policy
- KB Pharm's generic for Vildagliptin nitrate will be approved
- by Lee, Tak-Sun Dec 06, 2021 05:54am
- The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another. These items will be able to be released early in January next year if some of their duration is confirmed to be invalid. On the 30th of last month, three dosage products of Vildagliptin-Metformin HCl, a compound of KB Pharm, were approved. It is the seventh company to launch generic for Galvusmet. However, this is the first salt-changing drug containing Vildagliptin nitrate. Pharmaceutical companies participated in the development one after another. At first, only An-gook and Hanmi Pharm, which claimed invalidation of their duration, were developed, but when the Patent Tribunal achieved results, KOREA UNITED PHARM and KB Pharm also participated in the development. The lawsuit for invalidation of the extension of the duration ended on October 28 when the Supreme Court recognized 55 of the 1,068 extended days as invalid. If some of the invalidity of the duration is finalized, material patent of Galvusment will expire on January 9 next year. In this case, other pharmaceutical companies that have not participated in the lawsuit can also launch products on the market as their substance patents are terminated. Currently, generics for Galvusmet have been approved by Hanmi Pharm, KOREA UNITED PHARM, Ahn-gook, Ahn-gook Newpharm, Shinpoong, Samjin, and KB Pharm. However, Hanmi Pharmaceutical and KB Pharm are the only pharmaceutical companies that have been approved for three doses. The rest of the pharmaceutical companies were granted only 50/500 mg. In the case of generic for Galvusmet, there are no restrictions on selling products because there are no products that have received general for inclusion. In the case of single-drug Vildagliptin, Ahn-gook Newpharm has acquired generic for exclusivity, and the same drug will be banned from selling until May 29, 2022. Last year, Galvusmet recorded 36.4 billion won in outpatient prescriptions, continuing its popularity in the diabetes treatment market. Competition is expected to intensify when the generic market opens next year.
- Policy
- Asciminib's domestic approval is at a quick step
- by Lee, Tak-Sun Dec 06, 2021 05:53am
- Novartis' Asciminib, which is attracting attention as a fourth-generation targeted anticancer drug in the chronic leukemia treatment market, is also speeding up domestic permits. The drug, which was approved by the U.S. FDA last month, has recently been approved for four clinical plans in Korea alone, boosting the analysis that it is accelerating its entry into the Korean market. According to the MFDS on the 26th, Asciminib has been approved for four clinical plans since August. Asciminib is a TKI (tyrosine kinase inhibitor) family fourth-generation targeted anticancer, and is attracting attention in that it attacks targets different from those of the first to third generations. This is because different targets reduce interference between anticancer drugs. Chronic myelogenous leukemia treatment continued to evolve in 2001 when the world's first targeted anticancer drug, Glivec, was launched. The second generation was developed into Sprycel, Tasigna, and the third generation Iclusig. The survival rate of patients is also on the rise with the release of third-generation targeted anticancer drugs, but the rate of treatment failure due to resistance is known to increase as the treatment stage goes up. As a result, expectations for fourth-generation treatments are also growing. Asiminib is set to be officially released on October 29 as the FDA decided to approve. In Korea, the MFDS designated it as a rare drug for the "chronic Philadelphia chromosome-positive chronic myeloid leukemia" disease in May and opened the way for it to be used before official approval. If it is designated as a rare drug, it will be reviewed more quickly, so the speed of domestic approval is expected to accelerate. It is interpreted that it has considered expanding indications and bridging tests after a series of clinical approval permits. In August, a phase 3b test plan was approved to evaluate long-term safety in patients who completed the Asciminib clinical trial and judged that the tester would benefit from continued administration. In addition, in September, phase 1/2 was approved to determine the dose and safety of oral Asciminib in pediatric patients with chronic Philadelphia chromosome-positive chronic myeloid leukemia previously administered one or more tyrosine kinase inhibitors. On the 4th of this month, a phase 3b plan of oral Asciminib was approved in patients with chronic myelogenous leukemia in the chronic phase who had previously been administered two or more tyrosine kinase inhibitors. And on the 22nd, a phase 3 test of oral Asciminib versus TKI was approved in patients with newly diagnosed chronic myeloid leukemia positive for Philadelphia chromosomes. Industry sources say Asciminib is expected to speed up its approval in Korea with FDA approval, adding that approval is also possible as early as next year. The U.S. FDA has fully approved accelerated approval and chronic CML patients with T315I mutations for cases where two or more of Asciminib has been treated with Philadelphia chromosome CML patients, and it is known that the same indication is being reviewed in Korea.
- Product
- Why Tagrisso and Opdivo failed reimbursement expansions
- by Moon, sung-ho Dec 06, 2021 05:53am
- The 3rd generation targeted therapy for lung cancer, ‘Tagrisso (osimertinib)’ once again failed to expand reimbursement to first-line treatment. The reason was that the drug was more appropriate as a second-line treatment in terms of cost-effectiveness. By failing to expand reimbursement at the last Cancer Drug Review Committee meeting held this year, the two drugs will not have to wait until the next year to reattempt reimbursements. #According to the industry on the 26th, the National Health insurance Service held the 8th Cancer Drug Review Committee meeting on the 24th to deliberate on the reimbursement standards for drugs used by major cancer patients. As the last meeting planned for the year, the blockbuster drugs that were delayed deliberation due to data submissions from pharmaceutical companies and collecting academic opinions, the agenda of expanding reimbursement of the drugs was finally put on the table for deliberation. One representative drug that was put on the agenda for discussion was ‘Tagrisso (Osimertinib).’ With Tagrisso, which failed to extend reimbursement 3 times after adding an indication as a first-line treatment in lung cancer in December 2018, its company, AstraZeneca had attempted to receive approval once more with a more progressive cost-sharing plan. However, the company once again ‘failed.’ AstraZeneca had presented results from Phase III clinical studies conducted in China among others to support the need for extended reimbursement, however, the evidence provided by the company was not sufficient enough to convince the CDRC members. At the same time, the reimbursement approved for Tagrisso’s competitor, Yuhan Pharm’s ‘Leclaza (lasertinib),’ from the second half of this year as second-line treatment had also influenced the CDRC results. A CDRC official who requested animosity said, “We concluded that the use of Tagrisso or Leclaza as second-line treatment in line with the current reimbursement standards was more cost-efficient than using Tagrisso first-line as proposed. The cost-sharing proposal submitted by AstraZeneca was also adjusted and improved than before, it was not satisfactory. “ He added, “The discussions had been put on hold in the first half of this year because the level proposed by the company was not satisfactory in terms of cost-effectiveness. The other data submitted, such as the Chinese trial, were just referenced.” The CDRC also postponed the reimbursement extension for the cancer immunotherapy ‘Opdivo(nivolumab).’ Its company had applied to extend its reimbursement standards for melanoma, non-small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head, and neck cancer (240mg 2 weeks/480mg 4 weeks), but was unable to pass CDRC review. The CDRC official said, “Opdivo’s dosage was increased based on Europeans. Opdivo’s 240mg dose may be applied to Europeans in consideration of the 1kg/3mg dose recommendations as they weigh over 80kg.” He continued, “However, the average weight of Koreans is different from that of Europeans. They do not exceed 80 kg. Therefore calculating the dose by kg/3 mg is more cost-effective, but the company is attempting to expand reimbursement at a higher price.”
- Policy
- Companies in a dilemma over who bears losartan recall cost
- by Lee, Tak-Sun Dec 03, 2021 05:55am
- Pharmaceutical companies are unsatisfied with the health authorities’ request for companies to fully bear the cost of exchanging ‘losartan’ products that were found to contain azido impurities. While many companies have submitted the ‘cost-bearing letter of commitment,’ the companies have been left with a bitter aftertaste, due to the ongoing litigations and uncertainties on how much the exchanges will cost. Some companies have not submitted the letter of commitment yet. The Ministry of Food and Drug Safety had gathered the manufacturers and sellers of losartan products on the 29th of last month to request a ‘letter of commitment on bearing the cost,’ a commitment by the companies to bear the cost of exchanging, re-prescribing, and re-dispensing drugs that arise from recalls, saying that the cost should be borne by the pharmaceutical companies. After receiving the request, over half of the companies have submitted their letter by the 30th, the deadline for submitting impurity test results. Companies that submitted their letter of commitment did so because they do not expect the cost burden to be large, and that they could not disregard the government's request. An official from a mid-grade pharma company said, “ We submitted the letter of commitment as requested because we expect the number of recalls to be small, the number of products exchanged or re-prescribed by consumers to be even smaller.” As only specific lot numbers in issue are subject to recalls this time without stopping reimbursement, the companies expect the number of consumer recalls to be smaller than that for valsartan or ranitidine. In fact, the number of antihypertensive drugs that were recalled by consumers in September due to AZBT impurities was only 4, giving some credibility to these companies’ expectations. However, as there were no re-prescriptions, re-dispensing, and no public promotion activities informing the people about the recalls then, other companies believe the larger amount of recalls would increase the cost incurred as well. Another industry official said, “It may not have been so if the recalls were conducted quietly, but if the recalls become politicized, the cost of exchanging the products may grow bigger. Most of the losartan products are prescribed for long-term use, for over a month, and may become a big burden for pharmaceutical companies.” Another issue is that the letter of commitment may affect the ongoing non-existence of a debt suit being conducted on valsartan products. The suit arose after the National Health Insurance Service filed claims to pharmaceutical companies to retrieve the cost incurred while exchanging valsartan products that were found to have impurities. Companies have asserted that the indemnity claims were excessive as the unexpected impurities were only found due to the development of science and were unavoidable as the drugs were manufactured due process. However, the first trial court ruled in favor of NHIS and judged that a total of 2.03 billion won should be paid in claims for indemnity by 69 companies in September. The companies appealed, and the lawsuit is now being tried in a second trial. In this context, if the companies submit the ‘letter of commitment on bearing the cost,’ this contradicts the claims the companies had made at court and acknowledges indemnity. This is highly like to negatively affect the outcome of the lawsuit. This is why some companies have not been able to decide on whether to submit the letter of commitment. Recently, the MFDS is known to have been urging pharmaceutical companies to promptly submit the letter of commitment. A pharmaceutical company official said, “As the underdog, it would be difficult for us to reject the MFDS’ request. However, it is an unjust procedure for the government to unilaterally decide on the bearer of the costs and notify and companies to submit a letter of commitment.” Meanwhile, the MFDS is expected to soon announce a list of high blood pressure losartan drugs that contain excess azido-based impurities and start recalls from pharmacies, distributors, and consumers.
- Company
- Moderna Korea appoints Ji-Young Sohn as new GM
- by Dec 03, 2021 05:55am
- Ji-Young Sohn, General Manager of Moderna Korea Ji-Young Sohn, the former GM of CSL Behring Korea, was appointed as the General Manager of the Korean subsidiary of the COVID-19 vaccine developer Moderna. The new GM will be leading Moderna’s business in Korea and is seeking executives to organize teams that can perform various tasks for the company. The company is currently hiring new executives and employees. Sohn majored in Pharmacy at Ewha University and holds an MBA degree from Korea University Business School. Since then, she has accumulated over 20 years of experience in various global pharmaceutical companies. Before Moderna, the new GM had served as the General Manager of CSL Behring Korea and led the establishment of its Korean subsidiary and the launch of its new products. She started her pharmaceutical career at Pfizer Korea, then expanded her scope of business in the industry at Roche Korea and Roche Headquarters. At Pfizer Korea, Sohn had led various marketing and strategy teams and served as the Head/Director of the company’s first Specialty Care Business Unit. At Roche Korea, she had served as the Head of the Oncology Business Unit, driving strong growth of the oncology business and people development. After then, Sohn moved on to become an international portfolio business leader at Roche Headquarters Switzerland and successfully implemented a global strategy of a mature product portfolio worth 1 trillion won. Patrick Bergstedt, SVP of Commercial Vaccines at Moderna, said, “Sohn is a recognized innovative and strategic leader in Korea and global markets, and we look forward to working with her to reinforce Moderna’s place in Korea.” Sohn said, “Korea is a very important market for Moderna, and Moderna has already made various strategic partnerships and considerable investments in Korea. We will work to build major relations and introduce Moderna’s mRNA science technology to Korea, increase stakeholder trust, and strive to help promote the people's health with Moderna’s excellent vaccines and other future treatments to come."
- Company
- COVID-19 vaccinations freeze up the premium vaccine market
- by Chon, Seung-Hyun Dec 02, 2021 05:54am
- The premium vaccine market that consists of vaccines used to prevent diseases like shingles, pneumococcal vaccines, etc has contracted greatly. Analysts believe that the demand for other vaccines had decreased due to medical institutions prioritizing COVID-19 vaccinations. However, the cervical cancer vaccine market continued to show growth due to the increase in demand for Gardasil 9. On the 1st, according to the medical research institution IQVIA, the shingles vaccine market size in Q3 was ₩8.9 billion, down 56.1% from the same period of last year. The cumulative sales by Q3 in the market was ₩29 billion, also a 47.3% drop from last year. Currently, two products - MSD's ‘Zostavax’ and SK Bioscience's ‘Skyzoster’ – are competing in the domestic shingles vaccine market. Since Skyzoster broke the monopoly of Zostavax and entered the market at the end of 2017, the market had recorded rapid growth. The market size had increased to record ₩27.9 billion by Q4 in 2019. Quarterly sales of shingles vaccines (Unit: ₩1 million, Source:IQVIA) However, the market had fluctuated after the full outbreak of COVID-19. In Q1 last year, the shingles vaccine market decreased by 37.8% and recorded ₩12.2 billion. The market size had contracted with patients avoiding visits to medical institutions earlier on during the outbreak. Although the market showed recovery, increasing to ₩22.6 billion in Q2, ₩20.3 billion in Q2, then ₩17.3 in Q4, sales have once again made a downward turn entering this year. Sales in Q3 had fallen 68.1% compared to two years ago, in Q4 2019. Sales of Zostavax and Skyzoster have fallen together. Zostavax sold ₩5.7 billion in Q3, a 53% drop YoY. In the same period, Skyzoster sold ₩3.2 billion and dropped by 60.7%. compared to Q4 2019, when the two vaccines peaked in their sales, Zostavax and Skyzoster’s sales both fell by 66.2% and 70.9%, respectively. The sluggish performance of the shingles vaccine market is analyzed to be an effect of the increased COVID-19 vaccinations. That the medical institutions’ tendency to administer COVID-19 vaccines first had resulted in a relative neglection of other vaccine products, is most convincing. The pneumococcal vaccine ‘Prevenar 13’ that had temporarily enjoyed an upsurge in sales with COVID-19 is also seeing prolonged sluggish sales. Prevenar 13 sold ₩7.4 billion in Q3, which was a 69.6% decrease from the same period of last year. Its cumulative sales by Q3 were ₩24.9 billion, which was also an immense 58.5% drop from the previous year. Quarterly sales of Prevenar 13 (Unit: ₩1 million, Source:IQVIA) ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes (3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Prevenar 13’s performance this year is in stark contrast to the sharp rise in sales it made last year with the COVID-19 outbreak. Its sales in Q1 last year was ₩17.6 billion, a 52.2% increase from the previous year, which rose to ₩24.2 billion by Q3 last year. Prevenar13 sold ₩81.2 billion last year and made a 64.8% YoY increase. Demand for Prevenar 13 among adults had surged temporarily earlier in the COVID-19 outbreak with the expectation that while Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms from COVID-19. However, its sales had greatly dropped entering this year. Sales of the vaccine in Q1 was ₩9.4 billion, a 55.5% decrease from the previous quarter, and continued to drop in the following quarters. Prevenar13’s sales dropped 32.8% compared to the pre-COVID-19 period 2 years ago. In other words, the vaccine, which enjoyed reflective benefits in the early phases of the COVID-19 pandemic, has been on the contrary, been negatively affected by COVID-19 and the increase of its vaccinations this year. Among the various products in the premium vaccine market, the cervical cancer vaccines market solely showed growth. In Q3, the cervical cancer vaccine market increased 22.7% from the previous year and recorded ₩21.9 billion. Cumulative sales by Q3 was ₩66.9 billion, increasing 42.3% from the previous year. Three products – MSD’s ‘Gardasil,’ ‘Gardasil 9,’ and GSK’s ‘Cervarix’ – are competing in the domestic cervical cancer vaccine market. The rapid rise of the relatively expensive Gardasil 9 is analyzed to have driven the growth of the market’s size. Quarterly sales of cervical cancer vaccines (Unit: ₩1 million, Source:IQVIA) Gardasil sold ₩5.4 billion in Q3, which was only a 3.9% increase from the previous year. However, Gardasil 9’s sales rose 37.2% in the same period, recording ₩16.1 billion. Cumulative sales of Gardasil 9 by Q3 was ₩50.8 billion, a 72.6% increase from the previous year. Cervarix’s sales in Q3 were only in the ₩0.3 billion range. Gardasil 9 is a vaccine is an HPV vaccine product that contains 5 additional serotypes (31, 33, 45, 52, 58) to the 4 serotypes (6·11·16·18) contained in Gardasil. It is being distributed at a higher price Among cervical cancer vaccines, it is being distributed at a high price with the distinction that it contains the most HPV types. Based on Q3 numbers, Gardasil 9's accounts for 73.6% of the cervical cancer vaccine market. Unlike Gardasil and Cervarix, Gardasil 9 is not part of the National Immunization Program in Korea. However, its effect in preventing other HPV-related diseases such as anal cancer, genital warts, and precancerous lesions in addition to cervical cancer has spread by word of mouth, increasing the annual number of male vaccinations. The age for its vaccination had also been extended to cover up to 45 years of age, increasing the rate of adult revaccinations.
- Policy
- MFDS reviews Pfizer COVID-19 vaccine used without dilution
- by Lee, Tak-Sun Dec 02, 2021 05:54am
- On the 30th, the Ministry of Food and Drug Safety had announced that it had started reviewing the approval of Pfizer’s COVID-19 vaccine that does not require dilution – ‘Comirnaty inj. 0.1㎎/㎖ (registered name)’ – after the company applied for the authorization of its import product license. The product contains the same active ingredient as the previously approved Pfizer vaccine, ‘Comirnaty inj,’ but is more user-friendly as it may be used directly without dilution. Its single dose is 30㎍, same as that of the already approved vaccine. The ‘Comirnaty inj. 0.1㎎/㎖’ vaccine that is applying for approval this time comes in a vial with a gray cap, which can be differentiated from the purple cap of the already approved vaccine. The product has already been authorized(approved) in Europe and the U.S. The EU approval came on November 3rd and the US emergency approval on November 19th. The MFDS stressed that it will continue to be committed to the rapid provision of safe and effective vaccines for the Korean people.
- Policy
- Did Mooncare truly reinforce coverage for rare diseases?
- by Eo, Yun-Ho Dec 01, 2021 05:57am
- The voice requesting expanded coverage for patients with rare diseases had been exceptionally high this year in the 4th year of Mooncare. Starting with NA discussions held to enhance coverage of innovative new drugs for rare genetic disorders in May by the NA Health and Welfare Committee member Sunwoo Kang, NA members Byungwon Kang, Woni Kim, Young Seok Seo, Hyunyoung Shin held a public hearing to discuss ways to resolve the medically unattended areas, continuing on the effort to foster a policy environment that in which patients with rare diseases are not marginalized. The main contents that were discussed included the need to apply special exemption of calculation to diseases that are not being covered due to non-designation as a rare disease, and the strong proposal on the need to expand patient access to new rare disease treatments. The discussion continued to the NA Audit, where the NA Health and Welfare Committee member Sunwoo Kang, and members of the ruling and parties including JaeKeun In and Jongseong Lee all unilaterally urged improvement. ◆100% reimbursement rate for rare disease treatments in 2020? However, the public hearing revealed the different views held by the Health Insurance Review and Assessment Service. At the public hearing in May, HIRA presented that the reimbursement rate for rare disease treatments was 85.3%(2016~2020) and 100% in 2020. The numbers indicate that patient access to rare disease treatments is perfect. But if this is the case, why is the voice to expand reimbursement for rare disease treatments continuing to rise? 출처: 희귀유전질환 혁신신약 접근성강화를 위한 국회 토론회The results announced by HIRA were the reimbursement rate of drugs that went through the review and assessment process, not the actual reimbursement rate among all rare disease drugs. In other words, HIRA’s result excluded various factors including rejected and voluntarily withdrawn items. Data studied by the Korean Research-based Pharma Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association showed that only 50% of the pharmaceuticals that were designated orphan drugs over the past decade were listed on the reimbursement list. ◆Industry "Need to expand the pharmacoeconomic evaluation exemption system" The two associations joined forces to address the issue. Dailpharm found that KPBMA and KRPIA saw consensus on the need to expand accessibility to rare disease treatments and submitted a statement on the need to expand the pharmacoeconomic evaluation exemption system for rare disease treatments. In the statement, the two associations pointed out the existence of many rare diseases that greatly affect households with indirect medical costs and deteriorate the quality of life of patients but are not qualified for the ‘life-threatening (less than 2 years of life expectancy)’ condition that needs to be fulfilled to be able to utilize the current special exemption system (RSA and pharmacoeconomic evaluation exemption system) Therefore, the associations insisted that evaluating the ‘clinical need’ only with life expectancy does not take into account the characteristics of rare diseases, and diseases that do not meet the ‘less than 2-year life expectancy’ part of the clinical need requirement should also be allowed PE exemption if it is authorized through expedited approval processes abroad (US BTD, EU PRIME). The government had said that it would make efforts to improve access to rare disease treatments in the several public hearing and NA audits, but no specific plan or goal seems to be in place. An industry official said, “The government had recently adjusted the price evaluation criteria of PE exemption drugs by 20% from the lowest A7-adjusted price to improve the price transparency of PE exemption drugs. If the authorities decided to reduce the risk factors in price as such, they also should increase its scope of benefits.”
- Company
- Prevenar 13 sales take ‘roller-coaster’ ride with COVID-19
- by Chon, Seung-Hyun Dec 01, 2021 05:56am
- Sales of the pneumococcal vaccine ‘Prevenar 13’ took a rollercoaster ride in one year, enjoying an upsurge for a short period of time then plummeting in just a single year. The vaccine enjoyed reflective benefits in the early phases of the COVID-19 pandemic but dropped sharply after COVID-19 vaccinations began in earnest. According to the pharmaceutical research institution IQVIA on the 30th, Q3 sales of Prevenar 13 dropped 69.6% compared to the same quarter of the previous year and recorded 7.4 billion won. The cumulative sales by Q3 was 24.9 billion won, also a 58.5% decrease from last year, indicating sluggish sales. Such cases where sales of a product suddenly drops after making unprecedented records just a year ago are rarely observed. ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes. It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Quarterly Prevenar 13 sales trend (Unit: 1 million KRW, Source: IQVIA) Sales of Prevenar13 had been steadily rising before the COVID-19 pandemic, recording approximately 10 billion in quarterly sales. Then, its sales surged with the spread of COVID-19. Its sales in Q1 last year was 17.6 billion, a 52.2% increase from the previous year, and rose to 24.2 billion won by Q3 last year. Prevenar13 sold 81.2 billion last year, which was a 64.8% YoY increase. With the claim of some experts that although Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms of COVID-19 gaining credibility, demand for Prevenar 13 among adults surged temporarily. However, entering this year, its sales had greatly dropped. Sales of the vaccine in Q1 was 9.4 billion won, a 55.5% decrease from the previous quarter, and continued to drop across the following quarters. Analysts believe the rise in demand for Prevenar13 has been watered down due to the prolonged COVID-19 pandemic. Also, the start of COVID-19 vaccinations in earnest had affected the number of other vaccine recipients. Most of the vaccine market for adults is slow this year because of the priority given to COVID-19 vaccines. Also, other analysts see that the temporary surge in demand for COVID-19 vaccines last year lead to the relative gap in demand this year, and the demand for vaccination to reduce pneumonia symptoms has also decreased. The sluggish sales of Prevenar 13 also affected the performance of its distributor, Chong Kun Dang. Chong Kin Dang’s Q3 operating profit fell 23.7% from the same quarter of the previous year and recorded 37 billion won, and its sales recorded 341.3 billion won, a 4.5% YoY decrease.
- Company
- SGLT-2i Jardiance adds chronic heart failure indication
- by Eo, Yun-Ho Nov 30, 2021 05:52am
- The SGLT-2 inhibitor ‘Jardiance’ may now be prescribed for chronic heart failure in Korea as well. According to industry sources, the Ministry of Food and Drug Safety had additionally approved a new indication for Jardiance (empagliflozin),' the SGLT-2 inhibitor used for the treatment of diabetes, to be used for adults with chronic heart failure with reduced left ventricular ejection fraction, regardless of their diabetes status. With the approval, Jardiance became the second SGLT-2 inhibitor following ‘Forxiga (dapagliflozin)’ allowed to be prescribed for chronic heart failure. Forxiga had been approved for the same indication in December last year. Jardiance's heart failure indication was granted Fast Track designation, then approved by the US FDA in June. Its heart failure-related efficacy was confirmed through the Phase III EMPEROR-Reduced clinical trial. Results showed that Jardiance met the primary endpoint, composite of cardiovascular death or hospitalization for heart failure in adults, by reducing the risk by 25% compared to placebo, demonstrating statistical significance. In the analysis of key secondary endpoint, Jardiance reduced the risk of first and recurrent hospitalization for heart failure by 30% and significantly delayed the kidney function index, eGFR, compared to placebo. Also, the sub-analysis results of the EMPEROR-Reduced trial that were presented at the American Society of Nephrology (ASN) ‘Kidney Week 2020’ last year showed that Jardiance’s benefit was consistent across various patient subgroups including patients with severe renal dysfunction, regardless of chronic kidney disease status at baseline in the analysis for the overall population. Meanwhile, Jardiance also made remarkable achievements in acute heart failure. The Phase III EMPULSE study demonstrated Jardiance’s treatment benefit in patients who were hospitalized for acute heart failure. In the EMPULSE study which evaluated the efficacy and safety of Jardiance in adults with and without diabetes that were hospitalized for acute heart failure and have been stabilized, Jardiance demonstrated its clinical benefit by improving all-cause mortality, reducing cases of heart failure, and improving heart failure symptoms.
