EMPEROR-Reduced Label Analysis

Last week, FDA approved Jardiance for the treatment of HFrEF (view updated Jardiance label here; previous FENIX insight). The approval was based on results from the EMPEROR-Reduced CVOT which was first presented at ESC 2020; previous FENIX insight). As a reminder, BI/Lilly will be presenting full results from EMPEROR-Preserved as a Hot Line session at ESC 2021 on August 27 at 11:25AM ET (view ESC session). Recall, in July 2021, BI/Lilly announced positive topline results from the Ph3 EMPEROR-Preserved trial, but it did not provide any information on the magnitude of effect (previous FENIX insight). Below, FENIX provides thoughts on the new Jardiance HFrEF indication, including a favors/disfavors analysis for the HF market.

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.

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