FDA approves Regeneron’s garetosmab for ultra-rare bone-forming disease

The FDA has granted approval to Regeneron's antibody garetosmab, which targets activin A, for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is an ultra‑rare disorder that causes muscle and connective tissue to turn into bone.

Clinical data showed the drug can reduce heterotopic bone formation and improve mobility, addressing a long‑standing unmet need for patients with this condition.

The approval opens a new market for Regeneron and provides a therapeutic option for the small patient community affected by FOP, though access will be limited to those with a confirmed diagnosis.