CHMP joins FDA in challenging Tavneos’ approval basis

At its June meeting, EMA’s CHMP recommended revoking the marketing authorization for Amgen’s ANCA-associated vasculitis drug Tavneos due to data integrity concerns in the study supporting authorization, following a similar move by FDA.

The recommendation esclates scrutiny of Tavneos avacopan from Amgen Inc. (NASDAQ:AMGN), which began in January when FDA raised concerns about data integrity in the 331-patient Phase III ADVOCATE study that supported FDA’s 2021 approval and the European Commission’s 2022 marketing authorization. Amgen gained the small molecule C5aR inhibitor via its 2022 acquisition of ChemoCentryx Inc. for $3.7 billion...