AstraZeneca Says FDA Extends Review Period Of FibroGen's Anaemia Drug Roxadustat By Three Months

(RTTNews) - The US Food and Drug Administration has extended the review period of FibroGen's (FGEN) the New Drug Application or NDA for Roxadustat by three months, with an updated action date set for March 20.

Previously, the Prescription Drug User Fee Act (PDUFA) action date was scheduled for December 20.

Roxadustat is proposed for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients.

FibroGen and its partner AstraZeneca are collaborating on the development and commercialization of Roxadustat in the U.S., China, and other markets.

AstraZeneca said that the company and FibroGen are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to assist with the completion of labelling discussions.

Roxadustat is already approved in China and Japan under the brand name Evrenzo for both nondialysis-dependent and dialysis-dependent kidney patients.