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Jardiance EMPEROR-Reduced Approved by FDA

Here is a brief preview of this blast: BI/Lilly announced Jardiance received FDA approval for the treatment of HFrEF based on results from the EMPEROR-Reduced CVOT. The indication from the updated label reads "to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction." Of note, the approval comes ~3 weeks ahead of the projected PDUFA date (September 9, 2021). In June 2021, BI/Lilly received EC marketing authorization for Jardiance as a treatment for adults with symptomatic chronic HFrEF.

About The Author

Matthew Maryniak

President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.