FDA Approves Eli Lilly's Jardiance For Heart Failure

  • The FDA approves Eli Lilly And Co LLYBoehringer Ingelheim's Jardiance (empagliflozin) 10 mg for heart failure.
  • The approval comes to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).
  • Jardiance can be initiated in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m2.
  • The approval is based on results from the EMPEROR-Reduced Phase 3 trial.
  • In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% (5.3% absolute risk reduction) versus placebo. 
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: LLY shares are down 0.02% at $272.65 during the market session on the last check Wednesday.

Posted In: BriefsBiotechNewsHealth CareFDAGeneral

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