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Empagliflozin CV Outcomes Data: Is Sum Of The Parts Greater Than Whole?

 
• By Sue Sutter

Boehringer and Lilly focus on CV death, are not seeking broader indication for Jardiance based on less impressive primary composite endpoint results.

Boehringer Ingelheim GMBH and Eli Lilly & Co. will seek to convince an FDA advisory committee of Jardiance's (empagliflozin) strengths in reducing cardiovascular and all-cause death and heart failure-related hospitalization in the landmark EMPA-REG OUTCOME trial rather focusing on the study's less impressive primary endpoint results.

On June 28, FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review sNDAs for Jardiance and Synjardy (empagliflozin/metformin) based on results from the EMPA-REG OUTCOME trial

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