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- 2026-05-21 02:56:36
- Company
- Pfizer recalling Lipitor and Caduet in defective packaging
- by Jung, Hye-Jin Feb 11, 2020 06:29am
- Pfizer Korea is recalling some of Lipitor and Caduet stocks, not because of the drug itself but because of defective packaging. On Feb. 6, Pfizer Korea disseminated official notice to vendors and requested them to suspend shipping of Lipitor and Caduet. The shipping is halted for Lipitor 10 mg in 90-tablet packaging with manufacturer’s serial number DA1448 (expired by Apr. 15, 2022), CY0992 (expired by Apr. 15, 2022), and DA0505 (expired by Oct. 24, 2021), and Caduet 5/ 20 mg in 30-tablet packaging with serial number CR4181 (expired by Aug. 5, 2022). Pfizer Korea explained the company has found potential risk on product quality, and said it would voluntarily recall the products. The official notice stated, “Any healthcare institute or distributor with the said packaging in the stock should suspend shipping, and return the products to supplier when the recall is initiated.” Currently, Pfizer is discussing about the recall with Ministry of Food and Drug Safety (MFDS), and is also planning to notify related vendors and healthcare institutes about the recall method as soon as possible when it is decided. Pfizer Upjohn Korea official said, “The shipping suspension has been decided, because we found some bottled products with a crack on the rim of bottle opening. However, the ratio of products with the crack among the to-be-recalled products is estimated to quite low.” The company elaborated the potential risk on patient is low, but the preemptive steps are taken voluntarily to ensure safety of the patients.” Lipitor is hypertension-treating drug with atorvastatin that made 176.2 billion won in Korea last year. Caduet is a combination drug treating hypertension and dyslipidemia with atorvastatin and amlodipine. It has raised 24.1 billion won last year from prescription.
- Policy
- Strensiq, a rare disease treatment, passed the Committee
- by Lee, Hye-Kyung Feb 11, 2020 06:28am
- Strensiq, a rare disease treatment , passed the Pharmaceutical Benefits Advisory Committee On the 6th, the HIRA (Director Seung-taek Kim) revealed the results of the review by the Pharmaceutical Benefits Advisory Committee on the adequacy of the medical benefits of the drug application. Only one drug has been evaluated for adequacy of reimbursement, and is used to treat bone symptoms in children with hypophosphatemia which is Strensiq. Strensiq is a medicine that Handok signed a domestic sales contract for Soliris to strengthen its strategic partnership with Alexion on November 17 2016. It is a long-term enzyme replacement therapy for treating bone symptoms in children with hypophosphatemia in childhood. Clinical results in neonates and infants with hypophosphatemia showed that the survival rate at 1 year of age for patients who received 48 weeks of strains was 95%, significantly higher than the survival rate of 42% for historical control. The Committee stated that "the adequacy of the benefits of the strain is recognized", and "The final evaluation result may be changed in the event of changes in the specific reimbursement range and standard items of the drug, changes in the permission of the requested item, and withdrawal (cancellation)".
- Policy
- Phase 3 trial for Korea-made DPP-4 + SGLT-2 approved
- by Lee, Tak-Sun Feb 10, 2020 06:31am
- Apparently, Phase III clinical protocols of two new Korea-made anti-diabetic treatments based on DPP-4 inhibitor, Suganon (evoglitin by Dong-A ST) and Zemiglo (gemigliptin by LG Chem), have been approved to test their combination efficacy with SGLT-2 inhibitor drug. Among nine new dipeptidyl peptidase 4 (DPP-4) inhibitor drugs competing in Korean anti-diabetic treatment market, the two investigational drugs are rare cases of Korea-developed drugs. But also two of them have not yet confirmed combined efficacy with sodium-glucose cotransporter-2 (SGLT-2) inhibitor drug. Currently, MSD’s Januvia, Bristol-Myers Squibb’s Onglyza, and Boehringer Ingelheim’s Trajenta are indicated in Korea as combination therapy with SGLT-2 inhibitor. And recently, a few DPP-4 inhibitor plus SGLT-2 inhibitor combination drugs have been approved, but none of them are developed by a Korean company. On Feb. 7, Ministry of Food and Drug Safety (MFDS) has approved Phase III protocols on Suganon plus metformin plus dapagliflozin combination therapy and Zemglo plus metformin plus dapagliflozin combination drug. The health authority green lit Dong-A ST Suganon’s multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III trial that aims to test efficacy and safety of metformin plus evoglitin (brand name: Suganon) combination therapy added with dapagliflozin, treating type 2 diabetic patients with insufficient control of blood sugar level. LG Chem’s Phase III protocol on gemigliptin (brand name: Zemiglo) plus SGLT-2 inhibitor combination drug has been cleared to test efficacy and safety of metformin plus gemigliptin plus dapagliflozin combination therapy treating type 2 diabetic patients, who cannot sufficiently control blood sugar level after treated by metformin monotherapy. The Phase III trial would be multicenter, randomized, double-blind, double-placebo, active-control, parallel-group study comparing the investigational combination with dapagliflozin plus metformin combination therapy. Dapagliflozin apparent in both combination therapies is AstraZeneca’s SGLT-2 inhibitor anti-diabetic treatment, Forxiga’s active pharmaceutical ingredient. So far, Suganon has been indicated as monotherapy and combination therapy with metformin. And Zemiglo has been indicated as combination therapy with metformin, combination therapy with metformin plus sulfonylurea, and combination therapy with insulin. The most frequently used substance for anti-diabetic drug, DPP-4 inhibitor, controls blood sugar level by blocking enzyme dipeptidyl peptidase-4 to activate insulin-secretion stimulating hormone incretin. SGLT-2 inhibitor inhibits sodium-glucose transport protein 2 to prevent reabsorption of glucose in the kidney to lower blood sugar level. The medication is the newest drug in the anti-diabetic drug market rapidly increasing the volume in the market. Experts evaluate the combined use of two drugs would be more effective as both DPP-4 inhibitor and SGLT-2 inhibitor medications have confirmed outstanding efficacy of controlling blood sugar level and safety. But only limited number of drugs has been indicated as DPP-4 inhibitor plus SGLT-2 inhibitor combination therapy. Moreover, those drugs are all imported. The industry expects the Korea-made Suganon and Zemiglo to enhance their market competitiveness, when they win the SGLT-2 combination therapy indication. According to UBIST last year, Suganon has generated 7 billion won for outpatient prescription, and Sugamet, an evogliptin plus metformin combination drug, generated 8.6 billion. Moreover, Zemiglo has made 34 billion won, and its combination drug with metformin, Zemimet raised 63.5 billion won. The overall DPP-4 inhibitor market volume in Korea is approximately 500 billion won.
- Product
- Lyxumia by Sanofi stops supply in the second half
- by Kim, Min-Gun Feb 10, 2020 06:31am
- Sanofi-Aventis KoreaSanofi-Aventis Korea's supply of GLP-1 analog diabetes treatment ‘Lyxumia (Lixisenatide)’ will be discontinued from June this year. According to the distribution industry on the 7th, Sanofi recently announced that it has stopped supplying two formulations, such as 10μg and 20μg of Lyxumia pen, due to company circumstances. Sanofi said in an announcement that it is scheduled to withdraw its product license (from the Ministry of Food and Drug Safety) for the convenience of the company. If Lyxumia is withdrawn in March, the supply is expected to cease in June this year, when inventory held by wholesalers is exhausted. The remaining benefit period is expected to be up to six months from the date of withdrawal. As a result, benefits are expected to cease from October this year. The reason for the withdrawal of Lyxumia is unknown. However, the rapid decline in revenue after the advent of competitive products is believed to have had some effect on supply disruption. Licensed as a GLP-1 analogue in March 2013 by the Food and Drug Administration, the product was approved for glycemic control, diet and exercise therapy supplements in adult patients with type 2 diabetes. At the time of the market, once-daily administration showed attention for lowering blood sugar regardless of pre and post meal. However, Lixumia's sales declined sharply in 2016 because of Trulicity (Dulaglutide), which is administered once a week with the same GLP-1 analog family. According to drug market research institutes such as IQVIA, The sales fell to ₩500 million in 2018 and ₩300 million in 2019. The poor performance of the family of GLP-1 analogs administered once a day is not the only Lixumia. Victoza (Liraglutide) by Novonordisk and Byetta(Exenatide) by Astrazeneca also fell below ₩100 million. At present, the market size of the GLP-1 analogue is known to be about ₩30 billion. The industry believes that it is due to the convenience of once-weekly administration and Trulicity, which is recognized for its combination with basal insulin at the end of 2017. The long-lasting product has reduced the rejection of injections. This is a long-lasting product that has increased convenience. The market grew, but as Trulicity encroached, once-daily dosing products gradually disappeared.
- Company
- MSD’s Spin off completes within this year
- by An, Kyung-Jin Feb 10, 2020 06:31am
- Employees of Korean subsidiaries had begun to stir as Merck (US MSD) declares a division of business. Anxiety over future behaviors is heightening as the company announces the launch of an independent corporation to manage women's health-related products, patent expired drugs, and biosimilars within the year. #Decision to split MSD business, Transfer women's health and biosimilar products to a new corporation MSD held a conference call on the 5th and formulated a spin-off plan. The company plans to split the existing pharmaceutical division into two and set up a separate independent corporation (tentatively named NewCo) to focus on women's health-related products, cardiovascular diseases, respiratory and pain products, and biosimilar products. MSD has decided to focus its research and development (R&D) capabilities on remaining drugs, including anticancer drugs, vaccines, specialty products, and animal health. By item, About 90 patent-expired drugs such as ▲Biosimilars distributed by MSD headquarters such as Renflexis, Brenzys and Ontruzant through a contract with Samsung Bioepis ▲Etonogestrel implant Nexplanon franchise, birth control pills, maternity products, etc. ▲Hyperlipidemia drug, Zetia, Vytorin, respiratory disease drug Singulair, skin disease drugs, pain medicine, etc. will be transferred to the new corporation. Business split plan announced by MSD (Source: Merck Conference Call) Ken Frazier, CEO of Merck, said he decided to split the company to build a business model that fits the portfolio and expects both companies to focus on investment and growth in the first half of 2021. The company announced that it will proceed with the process of establishing a new corporation in the coming months. Based on the contraceptive and infertility related products currently owned by MSD, the goal is to foster new corporations as global leaders in women's health. The company also said it would seek opportunities for active partnerships with other pharmaceutical bio companies to maximize the value of cardiovascular and skin diseases, respiratory diseases, pain, and biosimilar products and to increase patient access. MSD plans to split the company within this fourth quarter, reorganization is imminent According to the headquarters policy, reorganization is inevitable even for a Korean corporation with 700 employees. MSD Korea held a town hall meeting for all employees on the 6th afternoon to share information on corporate division and had a Q&A time. According to officials who attended the Town Hall meeting, the management of the Korea MSD on the day set the standard that the employee's affiliation will follow the business unit to which the dedicated product portfolio belongs. Of the four divisions under the MSD of Korea, more than 100 employees from the DB (Diverse Brand) division dealing with respiratory and skin diseases such as Propecia and Singulair and some employees in the PC(Primary Care) with diabetes and cardiovascular diseases are influential. Since the new corporation is a completely independent company, the office will be operated separately after the spin-off. For example, sales marketing staff currently in charge of vaccine products such as Gardasil work at MSD, while sales marketing staff dedicated to DB business products such as Singulare are moved to a new corporation. The distribution criteria for employees who were in charge of both company's products or internal departments other than sales marketing department have not been specified yet. Since the company's affiliation may vary depending on the division's operating model, the company said that it would provide individual guidance on whether or not it belongs to the third quarter. The management of Korea MSD said, “It is expected that it will complete the spin-off within the fourth quarter of this year, regardless of the schedule of the headquarters. It is difficult to predict the number of employees who will be moving to a new corporation, except for clinical departments. Next week's departmental session will provide details”. Korean subsidiary's confusion aggravated, "no ERP implementation plan" by company Sudden decision adds confusion among employees. Employees attending the town hall are said to have asked questions about the succession of consecutive years of service and salary, benefits, and conditions of succession when they move to a new corporation. There is also anxiety that the ERP(Early Retirement Program) may be activated if the service years are not inherited or if the settlement of severance pay in the middle of business split. In this regard, a Korean MSD official said, “the company does not currently plan to settle interim severance pay or implement ERP. Years of service remain the same. Since the establishment of the new corporation, the company has not received any information from the headquarters regarding the sale and merger and acquisition plan”. He stressed, "It is not a cost reduction but a decision for long-term growth, so we plan to actively support the growth and career development of our employees after the division".
- Company
- AstraZeneca, decided to withdrawal from the KDPU
- by Kim, Jin-Gu Feb 10, 2020 06:31am
- AstraZeneca Korea decided to withdraw from the KDPU(Korea Democratic Pharmaceutical Union). The branches of the KDPU have been reduced to 18, including 17 multinationals and 1 domestic. According to the pharmaceutical industry on the 6th, the Branch of AstraZeneca Korea under the KDPU has voted for members whether or not to withdraw from the end of this January. As a result of the voting, More members were in favor of the withdrawal. After the withdrawal process, the union of AstraZeneka Korea will conduct collective bargaining with the company as an industrial union. AstraZeneca Korea's withdrawal from the KDPU is the third after Janssen Korea and Novonordisk. Prior to AstraZeneca Korea, the majority of members withdrew from the MSD Branch of Korea, but it did not lead to a complete withdrawal yet. At the end of last year, MSD Korea withdrew 300 members out of 380 members of the KDPU. There are currently two unions in the MSD Korea. Reasons for withdrawal include unequal voting rights and an increase in union costs. The KDPU are currently entitled to one vote per company regardless of the number of members. As a result, large companies continue to complain. It is reported that the union's executive department recently decided to raise union costs. In the case of large companies, the right to vote is limited and union costs have increased, which is a double burden. After the withdrawal of Jansen Korea, AstraZeneca Korea was the second largest after Novartis Korea. The KDPU was launched in 2012 by multinational companies under the Federation of Korean chemical Workers’ Unions. At the time, 8 companies including ▲Novartis Korea ▲Takeda Korea▲Sanofi-Pasteur ▲AstraZeneca Korea ▲Wyeth Korea ▲Zuellig Pharma Korea ▲ Bristol-Myers Squibb Korea and ▲Janssen Korea participated as founding members. Since then, ▲Baxter Korea ▲Merck KGaA ▲Ferring Pharmaceuticals, Korea ▲Allergan Korea ▲Fresenius Kabi Korea ▲Fresenius Medical Care ▲Abbvie Korea ▲Astellas ▲MDS Korea ▲Mundipharma Korea ▲Galderma Korea ▲Zuelligpharma services Korea joined as a new union branch. Among domestic companies, Kolon pharma has attracted attention by joining the union. Among them, Janssen Korea, Novonordisk and AstraZeneca Korea withdrew, and currently, there are 18 branches under the KDPU.
- Company
- Ilyang's Supect, good effect on leukemia cells reduction
- by Jung, Hye-Jin Feb 10, 2020 06:30am
- Ilyang announced that its phase III clinical trial of 'Supect', a leukemia treatment drug developed by the company, outperformed than Glivec. Ilyang Pharmaceutical (President Kim Dong-yeon) announced on the 6th that the clinical results were published in British journal of Hematology. In this trial, 241 patients with chronic myelogenous leukemia were administered to 24 hospitals in Asia (Korea, Thailand, Philippines, and Indonesia) for four years, and the results were followed by the administration of Supect, brand for Radotinib and the first generation of anticancer drugs 'Glivec'. According to the results, 86% of Supect administration group & 75% of Glivec administration group were the patients who received the major gene response who estimated to have reduced leukemia cells by more than 1000 times, and The complete gene response rate was 58% in the Supect-treated group and 49% in the Glivec group. According to Ilyang Pharmaceuticals, the treatment failure rate was 6% in the 300mg twice daily dose of SUPECT, more than three times less and 19% in the Glivec group. Kim Dong-Wook, Hematology Professor of Seoul St. Mary's Hospital, who led the clinical study and participated in the paper, said, “At 3 months after treatment, predicted long-term good genetic response rate was 86% in the Supect group and 71% in the Glivec group. The use of Supect is expected to result in a long-term treatment effect in a larger number of patients faster and significantly increase the number of patients who can stop drug treatment after using SUPECT for a period of time. Targeted anticancer drugs prescribed for patients with chronic myelogenous leukemia for the first time were Glivec, a first-generation anticancer drug, and a second-generation target anticancer drug, such as Supect from Ilyang Pharmaceutical, Tasigna by Novartis Switzerland, and Sprycel by Bristol Myers Squibb. Ilyang said, “The first diagnosis of chronic myelogenous leukemia patients showed faster and higher gene response rates in the 'Supect' group, and there was no new serious adverse reaction even after long-term follow-up, It was confirmed that the repair treatment could increase the possibility of Treatment Free Remission. And, the second generation of targeted anticancer drugs has been selected as the first treatment in many countries because of its superior efficacy than Glivec". In addition, "Supect, the second-generation targeted anticancer drug, is the inexpensive treatment cost, which can reduce the financial burden on patients and contribute greatly to the financial stability of national health insurance". A total of 20 researchers participated in the trial, including Professor Do Young-rok (first author), Department of Hematology and Oncology, Keimyung University Dongsan Medical Center and Professor, Dong-Wook Kim(corresponding author), Seoul St. Mary's Hospital.
- Policy
- HIRA to tighten personal data protection for committees
- by Lee, Hye-Kyung Feb 10, 2020 06:30am
- Drug reimbursement feasibility deliberating Health Insurance Review and Assessment Service (HIRA) plans to tighten operational regulation for its associated committees. The revised regulation would minimize collection of committee member’s private information and generally strengthen protection of personal information. HIRA’s Benefit Listing Department and Pharmaceutical Standards Department of Benefit Management Sector notified of revising operational regulation for ‘Drug Reimbursement Evaluation Committee (DREC)’ and ‘Cancer Disease Deliberation Committee (Cancer Committee),’ respectively. The current seventh DREC has a member pool of 100, where 19 of them are randomly selected to participate in regular meeting convened every first Thursday of a month. DREC decides listing of drug based on reimbursement standard, medical needs, clinical efficacy, cost-effectiveness and external reference country’s financial impact review result, when a pharmaceutical company applies for reimbursement covering a new drug. Six subcommittees associated under DREC—Drug Reimbursement Standards Subcommittee, Pharmacoeconomic Analysis Subcommittee, Risk Sharing Agreement Subcommittee, Financial Impact Assessment Subcommittee, Korean Herbal Drug Subcommittee, Drug Reevaluation Subcommittee—provide consultation on pharmacoeconomic analysis or review reimbursement standards for DREC to comprehensively evaluate feasibility of drug reimbursement. The eighth Cancer Committee has 43 members in its pool and regular meetings are convened on a Wednesday every month for two years from last Dec. 1. The committee deliberates standards of anticancer treatment reimbursement and off-label use of anticancer treatments. HIRA aims to revise their operational regulation to minimize collection of the 100 DREC members and 43 Cancer Committee members’ personal information and to clarify the personal data archiving period and third party personal data sharing record. Also, HIRA has decided to collect date of birth from the committee members, instead of Resident Registration Number. The revised regulation would remove the agreement for providing personal data and allowing personal identification information process, delete bank account number section on provided personal data, but substitute with ‘Consulting Fee and Travel Expense Certificate.’ The personal data archiving period would be stated as member’s term of two years, and the list of committee members would be posted on HIRA website.
- Policy
- Rucalo newly listed, Meqsel+Rafinlar expands reimbursement
- by Kim, Jung-Ju Feb 10, 2020 06:30am
- Healthcare reimbursement would be granted on Yooyoung Pharmaceutical’s chronic constipation treatment Rocalo tablet (prucalopride succinate) soon at a price of 100 won a unit. Used to treat BRAF V600E mutation-confirmed metastatic melanoma, Novartis Korea’s Meqsel (trametinib dimethyl sulfoxide) plus Rafinlar (dabrafenib mesylate) combination therapy would be additionally indicated for treating non-small cell lung cancer (NSCLC). But, only in condition of signing the expenditure cap type risk sharing agreement (RSA) for the financial issues. According to pharmaceutical industry on Feb. 5, the Korean government plans to reflect the said changes on ‘List of Reimbursed Drug and Maximum Reimbursed Price.’ ◆ Rucalo tablet: A selective serotonin 5-HT4 receptor agonist, Rucalo treats adults with chronic constipation, who does not respond to conventional laxative. After Ministry of Food and Drug Safety (MFDS) approved the drug as of Jan. 25 last year, the company immediately applied for reimbursement to Health Insurance Review and Assessment Service (HIRA) on Feb. 15 last year. Reimbursement on the drug was granted by Drug Reimbursement Evaluation Committee (DREC) in last October following the review by HIRA. Apparently, Korean Society of Neurogastroenterology and Motility’s claim that the doctors actually consider such prokinetic drug when a patient does not respond to first-line laxative (form-bulking or osmotic laxatives), has influenced the decision. In fact, the drug is listed in some of A7 countries like the U.K., Germany, Italy and Switzerland. Since then, the company successfully reached an agreement during pricing negotiation with National Health Insurance Service (NHIS) conducted from last November to early January, as ordered by MOHW. When the listing is completed, the drug’s maximum reimbursed price is predicted to be set at 127 won per 1 mg unit, and 191 won per 2 mg unit. ◆ Meqsel plus Rafinlar combination therapy expands reimbursement: Meqsel plus Rafinlar combination therapy has been indicated for treating metastatic melanoma in patient with confirmed BRAF V600E mutation. The combination has been receiving reimbursement since November 2017 in Korea. BRAF V600E mutation is a particular change in BRAF gene that affects growth and transmission of cancer cell and is frequently found in a number of specific cancers like melanoma. For the reimbursement review procedure, it took the pharmacoeconomic analysis exemption route. After a while, the pharmaceutical company added the therapy an indication to treat NSCLC patient with confirmed BRAF V600E mutation, and applied for expanded reimbursement to HIRA in February last year. HIRA’s Cancer Disease Deliberation Committee and DREC cleared reimbursement for the combination therapy in April and October last year, respectively. The combination therapy used on NSCLC, also recommended by clinical practice guidelines by National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO), was evaluated to have improved clinical efficacy when reviewed by DREC. However, the government and NHIS laid down a condition of signing RSA to cover the financial impact caused by expanding reimbursement on the combination therapy’s NSCLC-treating indication (NHI estimates yearly claim would be approximately 20 billion won). During the negotiation with the company later, the maximum prices of Meqsel and Rafinlar were lowered by 23% and 13%, respectively. When the new reimbursement is finalized, the maximum reimbursed price per unit is expected to be set at 128,344 won and 32,086 won per 2 mg and 0.5 mg of Meqsel, and 24,751 won and 36,336 won per 50 mg and 75 mg of Ranfilar.
- Company
- MFDS to clear Forxiga’s heart failure indication soon
- by Eo, Yun-Ho Feb 10, 2020 12:17am
- Anti-diabetic treatment Forxiga is ready to be reintroduced as a heart failure drug in Korean market as well. According to pharmaceutical industry on Feb. 7, AstraZeneca’s sodium-glucose cotransporter 2 (SGLT-2) inhibitor Forxiga (dapagliflozin) would be soon indicated for reducing the risk of hospitalization by heart failure in patients with type 2 diabetes. Korea’s Ministry of Food and Drug Safety (MFDS) is expected to conclude the review within this month at earliest. AstraZeneca started the additional indication approval procedure immediately after the U.S. Food and Drug Administration (FDA) has cleared of the indication in back October 2019. The company also aims to quickly process expanding an indication to reduce the risk of heart failure in patients with reduced ejection fraction, with and without type 2 diabetes, the FDA has processed under Priority Review. Forxiga’s efficacy to reduce the risk of hospitalization of diabetic patients with heart failure was confirmed during Phase III DECLARE-TIMI 58 trial. The large-scale trial observed 17,000 patients around the world with co-morbid type 2 diabetes and either cardiovascular-related risk or heart failure to study the effect of the SGLT-2 inhibitor on cardiovascular conditions. The outcome found Forxiga lowering the risk of hospitalization or death from heart failure by 17 percent and, specifically, the risk of hospitalization was lowered by 27 percent. The tendency of reduced risk of hospitalization by heart failure or death by cardio vascular disease was consistently prevalent in patient groups with cardiovascular risk factors (hypertension, dyslipidemia, smoking), and previous record of cardiovascular disease. Executive Director Chae In Ho of Korean Society of Interventional Cardiology (Professor at Seoul National University Bundang Hospital) stated, “Although heart failure treatment options are available, its medical need is still highly unmet. The use of SGLT-2 inhibitor for treating heart failure would be significantly popular in Korea.” Another SGLT-2 inhibitor, Boehringer Ingelheim’s Jardiance (empagliflozin) also has ongoing clinical trials to test indication to treat heart failure. The drug is simultaneously conducting EMPEROR-Preserved trial on patients with preserved ejection fraction and EMPEROR-Reduced trial on patients with reduced ejection fraction. Based on EMPEROR and EMPERIAL studies particularly testing efficacy on heart failure, FDA has reportedly granted fast track status on Jardiance’ heart failure indication.
