Empagliflozin for the treatment of heart failure
Empagliflozin was granted Breakthrough Therapy Designation following the publication of results from EMPEROR-Preserved, the first and currently only successful clinical trial in heart failure with preserved ejection fraction (HFpEF).
Recently, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to empagliflozin for the treatment of adults with heart failure with preserved ejection fraction ( HFpEF) investigational therapy. The breakthrough therapy designation is based on the results of the EMPEROR-Preserved Phase III clinical trial, which used cardiovascular death or hospitalization for heart failure in patients with HFpEF as a composite endpoint of the study.
Ivan Blanarik, Head of Cardiometabolic and Respiratory Therapeutics at Boehringer Ingelheim, said: “We are delighted that the FDA granted Empagliflozin Breakthrough Therapy designation shortly after the publication of the results of the EMPEROR-Preserved clinical trial for the treatment of HFpEF. Breakthrough Therapy Designation The sex therapy designation is a testament to our commitment to improving outcomes for patients affected by the cardio-renal-metabolic disease spectrum.”
Based on its high incidence, poor prognosis, and lack of clinically proven therapies, HFpEF has been called the single and largest unmet need in cardiovascular medicine. The disease is the leading cause of hospitalization for patients in the United States and Europe. Its prevalence continues to rise, with an estimated 30 million people worldwide affected by the disease, accounting for about half of all heart failure patients.
The breakthrough designation is granted to treatments for severe or life-threatening diseases that, based on preliminary clinical research evidence, may demonstrate substantial improvement in clinical endpoints compared to existing treatments.
Results of the EMPEROR-Preserved Phase III clinical trial were presented during a hotline session at the 2021 European Society of Cardiology (ESC) Congress and published concurrently 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 patients with heart failure with or without diabetes mellitus and reduced ejection fraction. Boehringer Ingelheim and Lilly Diabetes Alliance plan to submit a global registration application for the HFpEF indication in 2021.
Empagliflozin is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes drug to include data on cardiovascular mortality risk reduction in labelling in multiple countries.