AZ/Fibrogen Receive Roxadustat CRL

AstraZeneca and Fibrogen announced FDA issued a CRL regarding the roxadustat NDA for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. Recall, in July 2021, FDA held an advisory committee that voted 1-13 and 2-14 against the approval of roxadustat for the NDD and DD populations, respectively (previous FENIX insight). According to the press release, FDA is requesting additional clinical study be performed prior to resubmitting the roxadustat application. AZ and Fibrogen are working with FDA to evaluate next steps.

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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