FDA Grants Breakthrough Designation for Eli Lilly’s Diabetes Drug

FDA recently granted Breakthrough Designation for Eli Lilly & Company and Boehringer Ingelheim’s diabetes drug, Jardiance, as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF).

The agency based its decision on results from the landmark EMPEROR Preserved Phase 3 trial, which enrolled 5,988 individuals with heart failure.

Participants randomly received Jardiance 10 milligrams or placebo once daily. About 4,005 patients in the trial had a left ventricular ejection fraction (LVEF) of 50 percent or more, and 1,983 had an LVEF below 50 percent.

Overall, Jardiance elicited a 21 percent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure compared to placebo. 

Additionally, the drug reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent and substantially slowed kidney function decline. 

HFpEF accounts for nearly half of more than six million heart failure cases in the US. Currently, no approved treatments have been shown to significantly improve outcomes specifically for individuals living with the disease.

“Given the scarcity of treatment options for this debilitating condition, the benefits demonstrated in the EMPEROR-Preserved trial constituted a major clinical breakthrough,” Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly & Company, said in the announcement. 

“Together with our Boehringer Ingelheim partners, we look forward to working closely with the FDA through this accelerated process to potentially bring Jardiance to adults with heart failure with preserved ejection fraction as soon as possible,” Emmick continued.

In August, FDA approved Jardiance to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with HFrEF. 

The designation underscores the potential of Jardiance to help fill a critical need for a treatment for individuals living with this “highly prevalent, difficult-to-treat condition,” according to Mohamed Eid, MD, MPH, MHA, vice president of clinical development & medical affairs, cardio-metabolism & respiratory medicine at Boehringer Ingelheim.

“Following the recent FDA approval of Jardiance for heart failure with reduced ejection fraction, this is another important milestone supporting the potential of Jardiance as the first therapy clinically proven to improve outcomes across the full heart failure spectrum,” Eid concluded.