Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.
Boehringer Ingelheim and Eli Lilly’s blockbuster diabetes drug Jardiance (empagliflozin) received Breakthrough Therapy designation from the FDA as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF).
Last fall, the FDA also granted Fast Track designation to the two pharma makers to develop a new heart attack-related indication for Jardiance.
Sales of the popular diabetes medication increased 36% to $356.5 million in the second quarter of 2021, per Zacks Investment Research.
The Breakthrough Therapy decision is based on results from the landmark EMPEROR-Preserved phase 3 trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary end point of cardiovascular death or hospitalization for heart failure in adults with HFpEF compared with placebo, Boehringer Ingelheim and Lilly said in a news release.
HFpEF accounts for about half of the more than 6 million heart failure cases in the United States. No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF, the pharma makers said.
"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, M.D., Ph.D., vice president of product development at Lilly, said in a statement. "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."
Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 on August 27 and were also published in The New England Journal of Medicine.