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News 2026-09-25 23:00 UTC

Mirum, Incyte say FDA approves Atebrioz for FOP patients

The FDA approved Atebrioz (zilurgisertib) tablets for adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva. The companies said the treatment will be available in the U.S. in October through Mirum Access Plus, and the agency issued Incyte a rare pediatric disease priority revie

News 2026-09-25 23:00 UTC

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

Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (HO) in adult and pediatric patients aged 12 years and older…