Amgen has asked the FDA for continued approval review of Tavneos (avacopan), arguing the drug’s risk-benefit profile supports keeping it on the market amid concerns raised by the agency. The FDA’s scrutiny is reportedly tied to litigation involving the company that originally developed Tavneos, ChemoCentryx, and includes allegations around trial-data issues and safety. The dispute matters for rare vasculitis treatment continuity and highlights how FDA oversight is increasingly intertwined with post-approval legal and evidentiary challenges. An independent review process is part of Amgen’s strategy as the agency considers whether Tavneos should remain available or face withdrawal actions.