FDA Grants Breakthrough Therapy Designation to Empagliflozin for Heart Failure With Preserved Ejection Fraction


Empagliflozin demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure, compared with placebo.

The FDA has granted Breakthrough Therapy designation to empagliflozin (Jardiance; Eli Lilly) for the investigational treatment of heart failure with preserved ejection fraction, based on results from the EMPEROR-Preserved clinical trial.

EMPEROR-Preserved was a phase 3 international, randomized, double-blind trial enrolling 5988 adults both with and without type 2 diabetes. Participants were randomized to receive either once-daily empagliflozin 10 mg or placebo, in addition to treatment with guideline-directed heart failure therapy. The median follow-up time was 26.2 months and the composite primary endpoint was time to first event of cardiovascular death or hospitalization for heart failure.

Findings from the trial have established empagliflozin as the first therapy to show statistically significant improvement in heart failure outcomes among adults with heart failure and preserved ejection fraction, according to a press release. In the trial, empagliflozin demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure compared with placebo. Furthermore, this benefit was independent of ejection fraction or diabetes status.

Heart failure with preserved ejection fraction accounts for approximately 50% of all heart failure cases in the United States. Despite the common diagnosis, there are no currently approved treatments that have been clinically proven to improve outcomes, specifically for individuals with preserved ejection fraction.

“This Breakthrough Therapy designation underscores the potential of Jardiance to help fill a critical need for a clinically proven treatment for people with this highly prevalent, difficult-to-treat conditions,” said Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs with cardio-metabolism and respiratory medicine at Boehringer Ingelheim Pharmaceuticals, in the press release. “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.”

The Breakthrough Therapy designation is intended to help expedite the review of therapies for serious conditions in which preliminary evidence has found substantial improvements over available therapies. Empagliflozin was previously granted Fast Track designation to reduce the risk of cardiovascular death and hospitalization for heart failure. Results from the EMPEROR-Reduced trial were the basis of the recent FDA approval of the treatment of heart failure with reduced ejection fraction.

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


FDA Grants Jardiance Breakthrough Therapy designation for heart failure with preserved ejection fraction. News release. Lilly; September 9, 2021. Accessed September 9, 2021. https://investor.lilly.com/news-releases/news-release-details/fda-grants-jardiancer-breakthrough-therapy-designation-heart

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