Roxa Adcom Docs Released: FDA Mixed on Risk-Benefit

Today, FDA released the briefing documents for the July 15 roxadustat advisory committee. Overall, the documents have a mixed tone, making the outcome unclear for the two voting questions posed to the 15 voting panelists. Below, FENIX provides highlights and insights from the documents, including a prediction that the adcom vote will be split while still favoring Fibrogen/AZ due to the composition of the adcom panel.

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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