FDA Grants Priority Review for Jardiance to Reduce Risk of Cardiovascular Death

The FDA has accepted a supplemental new drug application and granted Priority Review for empagliflozin (Jardiance, Lilly) 10 mg, for a potential new treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure (HF) for individuals with HF independent of left ventricular ejection fraction, according to a statement from Boehringer Ingelheim and Eli Lilly and Company.

"If approved, Jardiance would be the first and only therapy clinically proven to significantly improve outcomes in a heart failure population that included a majority of people with preserved ejection fraction," Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs for cardio-metabolism and respiratory medicine at Boehringer Ingelheim, said in the statement. "The FDA's Priority Review designation further reinforces the urgent need for additional treatments for heart failure."

The application is based on results from the EMPEROR-Preserved phase 3 trial, where empagliflozin was associated with a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization HF in individuals over 40% compared with the placebo.

Empagliflozin is indicated to reduce the risk of cardiovascular death plus hospitalization for HF in individuals with HF and reduced ejection fraction.

The FDA previously granted Fast Track designation for the development of empagliflozin to reduce risk of cardiovascular death and hospitalization for HF.

Priority Review designation is intended to direct overall attention and resources to the evaluation of applications for a treatment that would be a significant improvement in the effectiveness or safety of treatment for serious conditions.

The findings were presented at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine.

Reference

US FDA accepts supplemental new drug application and grants Priority Review for Jardiance for adults with heart failure independent of left ventricular ejection fraction. EurekAlert. News release. November 11, 2021. Accessed November 12, 2021. https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-and-grants