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Lilly’s Jardiance Fast Track’d in U.S. to improve outcomes following heart attack

September 15, 2020

he FDA designates Eli Lilly’s (NYSE:LLY) type 2 diabetes med Jardiance (empagliflozin) for Fast Track review to prevent hospitalization for heart failure and reduce the risk of mortality in patients, with and without diabetes, who have had an acute myocardial infarction.

A Phase 3 clinical trial, EMPACT-MI, is in process.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

The company is developing and commercializing the product, along with others, with Boehringer Ingelheim under a 2011 agreement.

https://seekingalpha.com/news/3614077-lillys-jardiance-fast-trackd-in-u-s-to-improve-outcomes-following-heart-attack

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