FDA asks for more data on roxadustat; delays review
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FibroGen Inc. announced on Friday that the FDA is delaying a final review of the drug maker’s oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor – roxadustat – for 3 months.
The updated Prescription Drug User Fee Act (PDUFA) action date for the drug is now March 20, 2021, according to a company press release. FibroGen is collaborating with AstraZeneca in the development and commercialization of the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor to treat anemia in patients with kidney disease.
FibroGen is submitting additional analyses of existing roxadustat clinical data to the FDA, which requires an extension of the original PDUFA date, the company said in the release. “FibroGen is working closely with the FDA, in collaboration with our partner, AstraZeneca, to support the final review of the new drug application for roxadustat,” FibroGen CEO Enrique Conterno said in the release.
The FDA accepted the new drug application for roxadustat last February for treatment of anemia in patients with non-dependent CKD (NDD-CKD) and patients on dialysis. “The FDA’s acceptance of the roxadustat new drug application is a critical step toward providing a new treatment option in the United States for chronic kidney disease patients suffering from anemia, a serious and often life-threatening disease,” Conterno said at the time. Roxadustat is approved in China and Japan (under the name Evrenzo), and Chile for the treatment of anemia in patients with NDD-CKD and patients on dialysis, according to the release.
References:
www.healio.com/news/nephrology/20200212/fda-accepts-nda-for-roxadustat-for-ckdrelated-anemia