FDA grants priority review of empagliflozin for adults with HF, regardless of LVEF
The FDA has accepted a supplemental new drug application and granted priority review of empagliflozin for the reduction of CV death and HF hospitalization for adults with HF, regardless of left ventricular ejection fraction.
In September, the FDA granted breakthrough therapy designation for empagliflozin as an investigational treatment for adults with HFpEF.
According to a press release from Boehringer Ingelheim and Eli Lilly, the supplemental New Drug Application is based on the results from the EMPEROR-PRESERVED phase 3 trial.
As Healio previously reported, the SGLT2 inhibitor empagliflozin (Jardiance) was the first agent shown to improve clinical outcomes in patients with HFpEF, regardless of diabetes status; the results did not differ according to EF.
"This milestone offers renewed hope to adults with heart failure with preserved ejection fraction, for whom treatment options are especially lacking," Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly, said in the release. "We believe Jardiance has the potential to be a transformative treatment in heart failure and look forward to working with the FDA during the review process toward a decision next year."