Boehringer Ingelheim and Eli Lilly Report the US FDA’s Acceptance of sNDA and Granted Priority Review for Jardiance (empagliflozin) to Treat HFpEF

Shots:

• The sNDA is based on P-III EMPEROR-Preserved trial evaluates the safety and efficacy of Jardiance (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes
• The results showed a 21% vs 40% reduction in relative risk for the composite 1EPs of CV death or hospitalization in adults with HF with LVEF The results were presented at ESC 2021 and published in NEJM
• The therapy has previously received FTD from the US FDA to reduce the risk of CV death and hospitalization for HF & is currently indicated for adults with HFrEF. If Jardiance is approved, it will be the first clinically proven treatment for patients with HF regardless of ejection fraction

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