Asking Amgen to withdraw Tavneos, FDA revisits years-old data issue

FDA’s request that Amgen withdraw vasculitis drug Tavneos from the market revisits a data interpretation question considered by an agency advisory committee before its approval more than four years ago, with the committee split on whether the data supported the drug’s approval.

Amgen Inc. (NASDAQ:AMGN) said late Tuesday that it has informed FDA that it does not intend to withdraw Tavneos avacopan, although it remains in dialogue with the agency. Amgen gained Tavneos via its 2022 acquisition of ChemoCentryx Inc. for $4 billion...