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FDA Approves Second Treatment for Fibrodysplasia Ossificans Progressiva

The U.S. Food and Drug Administration has approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).

FOP is a very rare genetic disease in which connective tissues — including muscle, tendons, and ligaments — progressively transform into bone outside the skeleton, causing severe disability and early death. Pasatru is a targeted therapy that works by blocking a faulty protein in the body. In this disease, that protein sends abnormal signals that cause soft tissue to turn into bone. By disabling this protein, Pasatru stops those signals at their source, helping to prevent further abnormal bone growth.

Pasatru is administered as an intravenous infusion once every four weeks. It received Breakthrough Therapy, Fast Track, Orphan Drug, and Priority Review designations. The approval was granted to Regeneron Pharmaceuticals, Inc.

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