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FDA Starts Review of Regeneron's Drug for Rare Disease FOP

The FDA has placed Regeneron's anti‑activin A antibody garetosmab under priority review, with a decision expected by August. Phase 3 OPTIMA data showed a 94% reduction in new heterotopic ossification lesions at the lower dose and a 90% reduction at the higher dose, alongside a >99% drop in lesion volume. Approval would give patients a second option to Ipsen's oral RAR gamma agonist Sohonos, which has struggled commercially. Regeneron also announced a pediatric Phase 3 trial (OPTIMA 2) to begin later this year.