Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva

Mirum and Incyte announced FDA approval of Atebrioz (zilurgisertib) for adult and pediatric patients with fibrodysplasia ossificans progressiva, a rare and debilitating genetic disease. The approval creates a new commercial opportunity for the companies in an underserved rare-disease indication and materially de-risks the therapy's regulatory pathway.