DECLARE Hits on HF Endpoint but Not 3P-MACE; Bad News for CANVAS Review?

AstraZeneca announced that results from the Farxiga CVOT, DECLARE, demonstrated superiority for the “CV death or hospitalization for heart failure (hHF)” composite endpoint, but did not meet statistical significance for 3-point MACE. Full results from the study will be presented at the American Heart Association conference on November 10 at 345pm CST by TIMI’s Stephen Wiviott. Below, FENIX provides thoughts on the topline results as well as insight into potential negative read-through to the CANVAS/R review for Invokana.

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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