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DPP-IVi, SGLT2i

UPDATED: Invokana 3P-MACE Indication Approved

Here is a brief preview of this blast: Janssen announced FDA approved Invokana and its metformin FDCs for the reduction of 3P-MACE in patients with T2DM and established CVD. The approval comes slightly later than the 3-month PDUFA extension FDA requested on July 13, 2018. Below, FENIX provides thoughts on how the CANVAS/R approval will impact the SGLT2i market, including potential read-through to AZ's DECLARE (full results to be presented at AHA on November 10), and potential inclusion on updated guidelines.

About The Author

Matthew Maryniak

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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.