CREDENCE Priority Review for Invokana; PDUFA Projected in Late September 2019

Janssen announced that FDA granted Priority Review for the Invokana CREDENCE renal outcomes sNDA which shortens the review time to 6 months. Recall, on March 28, 2019, Janssen announced the sNDA filing which suggests the PDUFA is on or around September 28, 2019. Below, FENIX provides an updated approval timeline as well as thoughts on how a renal protection indication may help to turn around the declining Invokana franchise.

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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