 HomeNewsEmpagliflozin was recognized as a breakthrough therapy by FDA for the treatment of heart failure with retained ejection fraction

Empagliflozin was recognized as a breakthrough therapy by FDA for the treatment of heart failure with retained ejection fraction

2021-09-16

Boehringer Ingelheim and Eli Lilly, Inc. (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Englezin as an investigational therapy for the treatment of adult heart failure with ejection fraction retention (HFpEF). This breakthrough therapy designation was based on the results of a EMPEROR-Preserved Phase III clinical trial that included cardiovascular death or hospitalization for heart failure in patients with HFpEF as the study's composite end point.

Ivan Blanarik, Head of Boehringer Ingelheim's Cardio-metabolic and respiratory therapies, commented, "We are pleased that the FDA granted breakthrough therapy designation for Englizein shortly after the publication of results from a emper-preserved clinical trial for HFpEF. The breakthrough therapy designation is a testament to our commitment to improving outcomes for patients affected by the cardio-nephro-metabolic spectrum."

HFpEF has been called the single largest unmet need in cardiovascular medicine due to its high incidence, poor prognosis, and lack of clinically approved therapies to date. Prevalence of the disease, the leading cause of hospitalization in the United States and Europe, continues to rise, and is estimated to affect about 30 million people worldwide, or about half of all heart failure patients.

Breakthrough designation is awarded to therapies for severe or life-threatening diseases that have preliminary clinical evidence that they may show substantial improvement in clinical endpoints compared to existing therapies.

Results from the Emper-preserved Phase III trial were presented during a hotline session at the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in the New England Journal of Medicine.

Empagliflozin is currently used to treat adults with type 2 diabetes who have poor glycemic control. In addition, Empagliflozin is approved in the European Union and the United States for the treatment of adult heart failure patients with or without diabetes and a reduced ejection fraction. Boehringer Ingelheim and Lilly's Diabetes Alliance plan to register HFpEF globally in 2021.

About Empagliflozin

Empagliflozin (marketed as Jardiance ®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that is the first type 2 diabetes drug to include data on reducing the risk of cardiovascular death in many countries.

Previous: Astellas` and Pfizer`s XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study

Next: Rheumatoid arthritis: who is better, tofatib or barretinib?

 HomeNewsEmpagliflozin was recognized as a breakthrough therapy by FDA for the treatment of heart failure with retained ejection fraction

Shandong Haohong Biotechnology Co., Ltd.