HealthFDA Approves Regeneron Pasatru for FOP
Regeneron's garetosmab, marketed as Pasatru, received FDA approval to treat adults with fibrodysplasia ossificans progressiva, becoming the second FDA-cleared therapy for FOP and the first to reduce clinician-assessed flare-ups. Driven by OPTIMA/phase 3 data showing about 90% reduction in new bone lesions over 56 weeks and substantial decreases in flare-ups, Pasatru competes with Ipsen's Sohonos and awaits EMA/Japan submissions, with price not disclosed.
