Regeneron says FDA approves Pasatru for adults with rare bone disorder FOP
REGN•FDA approves Pasatru for adults with FOP
Regeneron says the FDA approved Pasatru (garetosmab-grts) to curb new HO lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
The decision drew on Phase 3 OPTIMA data showing a 90%–94% drop in new lesions at 56 weeks versus placebo.
The company said its EU filing remains under review at the European Medicines Agency.
