FDA Approves Second Drug for Ultra-Rare Bone Disease FOP

The FDA approved garetosmab (Pasatru) to reduce new heterotopic ossification lesions and disease flares in adults with fibrodysplasia ossificans progressiva (FOP). In a phase III trial, the monoclonal antibody reduced new bone lesions by 90-94% and flares by up to 88% compared with placebo. This is the second approved treatment for FOP, following palovarotene in 2023.