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

November 12, 2021 Auto Bot Boehringer Ingelheim, Clinical Trials, Eli Lilly, Empagliflozin, FDA, Jardiance, Priority Review, sNDA 0

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

Click here to­ read the full press release/ article | Ref: PR Newswire | Image: Longevity Technology

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