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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA approved garetosmab-grts (Pasatru, Regeneron), a monoclonal antibody for adults with fibrodysplasia ossificans progressiva (FOP) — a rare condition where soft tissues gradually turn to bone. In a phase 3 trial, the drug cut new bone lesions by up to 94% compared to placebo. It works by blocking Activin A, the protein that triggers abnormal bone growth in FOP patients.
The FDA has approved garetosmab-grts (Pasatru, Regeneron), a monthly IV monoclonal antibody for adults with fibrodysplasia ossificans progressiva (FOP) — a devastating rare disease where muscles, tendons, and ligaments progressively turn into bone, forming a "second skeleton" that robs patients of mobility. The drug works by blocking Activin A, a protein that drives abnormal bone formation in FOP, and is the first FDA-approved therapy specifically targeting new heterotopic ossification lesions in this condition.
Approval was based on the phase 3 OPTIMA trial involving 63 adults. Pasatru can be administered in flexible care settings, including home infusion, with a starting dose of 10 mg/kg and an option to reduce to 3 mg/kg for tolerability. A pediatric trial is planned to launch later in 2026.
By the Numbers:
Why it matters: FOP is relentlessly progressive, and every new lesion can mean permanent loss of function. Pasatru joins Ipsen's Sohonos (approved 2023) in offering patients a meaningful way to slow that progression — a significant step forward for a disease that went without approved treatments for decades.
