FDA 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.
Health · 6 sources · Aug 19, 2026Read itThe journal
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About fibrodysplasia ossificans progressiva
Fibrodysplasia ossificans progressiva, also called Münchmeyer disease or formerly myositis ossificans progressiva, is an extremely rare connective tissue disease. Fibrous connective tissue such as muscle, tendons, and ligaments ossify into bone tissue. The condition ultimately immobilises sufferers, as new bone replaces musculature and fuses with the existing skeleton. This has earned FOP the nickname "stone man disease".
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