Amgen submitted a new analysis to the FDA intended to support maintaining Tavneos (avacopan) on the market amid an ongoing regulatory dispute over the rare disease product. The company said the additional package includes an independent reevaluation supporting its benefit-risk position, signaling that Amgen is pressing for continued access rather than pursuing a narrower path such as label restrictions. The FDA decision timeline will shape patient access and the company’s follow-on development strategy in immune and rare disease portfolios, where evidence expectations can be decisive for continued commercialization.