Ultra-rare fibrodysplasia ossificans progressiva now has its second approved drug
— Ultra-rare fibrodysplasia ossificans progressiva now has its second approved drug
by Ian Ingram, Managing Editor, MedPage Today
August 19, 2026
• 2 min read
The FDA approved garetosmab (Pasatru) to reduce the formation of new heterotopic ossification lesions and disease flares in adults with fibrodysplasia ossificans progressiva (FOP), the agency announced on Wednesday.
The FDA approved a novel therapy for reducing the formation of heterotopic ossification lesions and flare-ups for adults with…
Regeneron Pharmaceuticals secured FDA approval for Pasatru, a novel monthly infusion therapy proven to reduce lesions in FOP…
After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now…
CHICAGO — Garetosmab reduced new heterotopic bone lesions in patients with fibrodysplasia ossificans progressiva at 56 weeks…
CHICAGO — In patients with fibrodysplasia ossificans progressiva, an oral selective inhibitor of activin receptor–like kinase 2…
FDA approved Regeneron's Pasatru (garetosmab) for FOP, a rare disease affecting ~900 patients. Annual list price ranges…
