Regeneron wins FDA approval for Pasatru for FOP
Regeneron won FDA approval for Pasatru (garetosmab-grts) to reduce new heterotopic ossification and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). The intravenous monthly monoclonal antibody blocks Activin A and starts at 10 mg/kg, with an option to decrease to 3 mg/kg. Approval rested on the Phase III OPTIMA trial of 63 patients, in which Pasatru produced up to a 90% reduction in new lesions at the higher dose and cut flare-ups at two doses after 56 weeks. The drug enters direct competition with Ipsen's Sohonos, while Regeneron has not disclosed pricing.
Pasatru cut new heterotopic ossification lesions by up to 90% in OPTIMA.
Context
Sohonos was the only approved therapy after its FDA approval in 2023. Regeneron's approval follows the OPTIMA Phase III trial of 63 patients that showed large lesion reductions. Next, payers, clinicians and patients are likely to compare…
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