Empagliflozin Receives FDA Priority Review for Heart Failure Indication Across All Ejection Fraction Ranges

Today, Eli Lilly and Boehringer Ingelheim jointly announced that the U.S. FDA has granted Priority Review status to the supplemental New Drug Application (sNDA) for their jointly developed SGLT2 inhibitor empagliflozin, aimed at reducing the risk of cardiovascular death and hospitalization in heart failure patients, regardless of their left ventricular ejection fraction. The press release noted that if approved, empagliflozin could become the first therapy to significantly improve clinical outcomes across the full spectrum of heart failure patients.

Empagliflozin is a once-daily oral, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. In patients with type 2 diabetes with higher blood glucose levels, inhibiting SGLT2 prevents the kidneys from reabsorbing sugar, allowing more sugar to be excreted through urine. Additionally, empagliflozin prevents the reabsorption of salt, increasing salt excretion in the body and reducing fluid load in the vascular system. The changes in sugar, salt, and water metabolism induced by empagliflozin may help reduce cardiovascular death. Earlier this year, it received FDA approval for reducing the risk of cardiovascular death and hospitalization due to heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

▲EMPEROR-Preserved Trial Primary and Key Secondary Endpoint Data (Image Source: Reference [2])

This supplemental new drug application is based on the positive results of the Phase 3 clinical trial EMPEROR-Preserved. Empagliflozin achieved the primary endpoint of the trial, reducing the relative risk of cardiovascular death or hospitalization for heart failure by 21% in adults with heart failure with preserved ejection fraction (HFpEF) compared to placebo. The trial also met its key secondary endpoint, showing that empagliflozin reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% and significantly slowed kidney function decline. In terms of safety, the overall safety data were consistent with previous results, confirming the established safety profile of the drug.

References:

[1] US FDA accepts supplemental New Drug Application and grants Priority Review for Jardiance® for adults with heart failure independent of left ventricular ejection fraction. Retrieved November 11, 2021, from https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-and-grants

[2] Anker et al., (2021). Empagliflozin in Heart Failure with a Preserved Ejection Fraction.NEJM, DOI: 10.1056/NEJMoa2107038

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