US FDA approves Mirum’s drug for rare bone disorder

Atebrioz: US approves drug for rare bone disorder

The once-daily drug zilurgisertib, branded as Atebrioz, is approved for patients aged 12 years and older with fibrodysplasia ossificans...

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

FOSTER CITY, Calif. & WILMINGTON, Del.--(BUSINESS WIRE)--Sep 25, 2026-

US FDA approves Mirum's drug for rare bone disorder

Mirum wins FDA Atebrioz approval for FOP patients 12+

Mirum expects U.S. availability in October after a 63-patient study; its prespecified new-lesion incidence endpoint missed the conventional threshold.

FDA approves Mirum’s drug for ultra-rare soft tissue disease

The FDA has approved the third treatment for a debilitating genetic disease that turns muscle and connective tissue to bone. Mirum Pharmaceuticals’ zilurgisertib, which blocks the ALK2 receptor, will be marketed as Atebrioz for patients ...