Vadadustat PDUFA Passed?

The vadadustat PDUFA date was on March 29, 2022; however, no press releases have been observed by Otsuka/Akebia nor has anything been posted on Drugs@fda. As such, it remains unclear if FDA will still approve the NDA in the coming days, issue a CRL, or potentially extend the PDUFA date. Presumably, the companies will have to issue a press release once they officially hear from FDA. Below, FENIX provides brief thoughts on the missed PDUFA date.

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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