European Commission Grants Marketing Authorization for Jardiance® (empagliflozin) to Treat Heart Failure with Reduced Ejection Fraction
Boehringer Ingelheim
Developer of Innovative Drugs and Therapies
Eli Lilly
Global Pharmaceutical R&D and Production Company
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
INGELHEIM, Germany, June 22, 2021 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company announce that the European Commission has granted marketing authorization for Jardiance® (empagliflozin) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure).[1]The expansion of Jardiance's indications follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on May 20, 2021.
Dr. Faiez Zannad, Clinical Investigator of the EMPEROR trial and Honorary Professor at the Faculty of Medicine, University of Lorraine, France, stated: “The approval of this indication provides a vital, novel treatment option, thereby helping millions of patients in Europe with symptomatic chronic heart failure with reduced ejection fraction. New therapies such as empagliflozin can save lives, reduce hospitalizations, and allow patients to spend more time with their families.”
The marketing authorization is based on the EMPEROR-Reduced clinical trial, with study results demonstrating that compared with placebo, empagliflozin significantly reduced the risk of the composite endpoint of cardiovascular death and hospitalization for heart failure by 25%.[2] Primary endpoint results were consistent across patient subgroups with and without type 2 diabetes. Analysis of key secondary endpoints demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalizations for heart failure by 30% and significantly slowed the decline in renal function.[3]
Dr. Waheed Jamal, Vice President and Head of Medical, Cardiometabolism at Boehringer Ingelheim, stated: “Jardiance is the first SGLT2 inhibitor proven to provide cardiovascular protection and improve cardiovascular outcomes in patients with type 2 diabetes. We are pleased to now offer Jardiance to patients with heart failure with reduced ejection fraction, both with and without diabetes. We look forward to collaborating with regulatory authorities in Europe and other regions to ensure patient access to this trusted therapy.”
Dr. Jeff Emmick, Vice President of Product Development at Eli Lilly and Company, said: "As we enter a new chapter in heart failure management, we now look forward to the results of the EMPEROR-Preserved trial, which are expected to be released this year. The trial investigates empagliflozin for the treatment of adult patients with heart failure with preserved ejection fraction, both with and without diabetes. We are committed to seeking solutions for millions of patients worldwide living with heart failure and important metabolic diseases."
Heart failure is often associated with other cardiorenal-metabolic diseases, such as type 2 diabetes and kidney disease. Due to the interconnectedness of these systems, improving the health of one system can have a positive impact on the others. Heart failure is a very common and severe complication of myocardial infarction,[3],[4]It occurs when the heart is unable to pump sufficient blood to the rest of the body. There are two forms of heart failure: heart failure with reduced ejection fraction means the heart cannot contract properly, while heart failure with preserved ejection fraction means the heart cannot fill with blood normally. Patients with heart failure often experience shortness of breath and fatigue, which can significantly impair their quality of life.[5],[6]
The EMPEROR-Reduced trial is part of the EMPOWER clinical trial program, the most extensive and comprehensive clinical trial program for any SGLT2 inhibitor, designed to evaluate the impact of empagliflozin treatment on the lives of patients with various cardiorenal-metabolic diseases.