CREDENCE sNDA Filed; Priority Review Unclear

Janssen announced it has filed an sNDA for the Invokana renal outcomes study, CREDENCE. Full results from CREDENCE are scheduled to be presented on April 14 at the World Congress of Nephrology meeting. Recall, on July 16, 2018, Janssen announced that CREDENCE stopped early for positive efficacy findings. Of note, Janssen’s press release did not state whether the company requested a priority review by FDA. Below, FENIX provides thoughts on the CREDENCE filing and potential approval timelines based on whether or not FDA grants priority review.

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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