Regeneron (NASDAQ:REGN) reported positive results from its Phase 3 Optima trial evaluating garetosmab in adults with fibrodysplasia ossificans progressiva (FOP), showing significant reductions in new bone formation.
At the 56-week assessment, both dose levels outperformed placebo substantially. Patients receiving 3 mg/kg experienced a 94% decrease in new bone lesions, while those on the 10 mg/kg dose saw a 90% reduction.
Following these results and the favorable safety profile, the Independent Data Monitoring Committee recommended that participants on placebo switch to garetosmab as soon as possible.
Regeneron plans to file for U.S. regulatory approval for garetosmab in adults by the end of 2025, with global submissions anticipated in 2026. Additionally, the company intends to launch a Phase 3 trial in adolescents and children with FOP next year, expanding potential access to this rare bone disorder therapy.
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