Amgen Inc.
(NASDAQ:AMGN) has formally requested a hearing to challenge the U.S.
Food and Drug Administration's proposal to withdraw approval for Tavneos (avacopan).
The company argues that the drug's benefits continue to outweigh its risks for patients with a rare autoimmune disease.
The request, submitted by Amgen and its subsidiary ChemoCentryx, Inc., responds to a Notice of Opportunity for a Hearing issued by the FDA's Center for Drug Evaluation and Research (CDER) on April 30 regarding Tavneos.
