FDA approves Regeneron's Pasatru for rare bone disorder FOP
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Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial i
August 19, 2026 1:58 PM EDTFOP is an ultra-rare genetic disorder characterized by rogue bone formation that infiltrates muscles, tendons, ligaments and other connective tissues, resulting in significant disabilityÂ
Approval based on results from the OPTIMA trial demonstrating a 90% or greater reduction in new HO lesions at 56 weeks with a dramatic reduction in clinician-assessed flare-ups in adults with FOP
TARRYTOWN, N.Y., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru (garetosmab-grts) to reduce formation of new heterotopic ossification (HO) lesions... More
