Benzinga | Aug 11, 2021 07:00AM EDT

Fibrogen Reports Received Complete Response Letter From FDA For Roxadustat For Anemia

FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).

The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted, prior to resubmission.

"We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States," said Enrique Conterno, Chief Executive Officer, FibroGen. "Roxadustat is changing the lives of patients around the world, and we and our partner AstraZeneca will discuss next steps in the U.S."

Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency's committee responsible for human medicines. The European Commission decision is expected by the end of August.