AstraZeneca : FDA Requests More Analysis for Approval of Roxadustat

By Sabela Ojea

AstraZeneca PLC said Monday that the U.S. Food and Drug Administration has requested further analysis of clinical data of its Roxadustat drug to complete the review of the new drug application.

The British-Swedish pharmaceutical giant said it will submit along with FibroGen, Inc. additional data to assist with the completion of labeling discussions.

The FTSE-100 listed company added that the new drug application is still under regulatory view, noting that the FDA has set a new action date of March 20, 2021.

The Roxadustat-drug is an oral inhibitor for patients with anemia of chronic kidney disease.

Write to Sabela Ojea at [e-mail]; @sabelaojeaguix

(END) Dow Jones Newswires

12-21-20 0229ET