Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction

September 10, 2021 Auto Bot Boehringer Ingelheim, Breakthrough Therapy Designation, Eli Lilly, Empagliflozin, heart failure, Jardiance, regulatory 0

Shots:

  • The designation is based on the P-III EMPEROR-Preserved trial evaluates the safety and efficacy of empagliflozin (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes
  • The results demonstrated a 21% reduction in risk for the composite 1EPs of CV death or hospitalization for adults with HF. The results were presented at ESC 2021 & published in NEJM
  • Empagliflozin has previously received FTD from FDA to reduce the risk of CV death and hospitalization for HF & is approved for HFrEF with/out diabetes in the EU & US. Additionally, the companies plan for global regulatory submissions for HFpEF in 2021

Click here to read full press release/ article | Ref: Lilly | Image: Reuters

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