FDA approves garetosmab for adults with FOP - Takeaways - MDSpire
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FDA approves garetosmab for adults with FOP

In the phase 3 OPTIMA trial, the 10-mg/kg and 3-mg/kg doses reduced new heterotopic ossification lesions by 90% and 94%, respectively, compared with placebo at 56 weeks.

  • By

  • Kathryn Wighton

  • August 20, 2026

  • 3 min

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  • 1

    The FDA approved garetosmab for adults with fibrodysplasia ossificans progressiva to reduce new heterotopic ossification lesions.

  • 2

    The recommended starting dose of garetosmab is 10 mg/kg, administered intravenously every 4 weeks.

  • 3

    The approval was based on findings from the phase 3 OPTIMA trial, which involved 63 adults with FOP.

  • 4

    Patients receiving garetosmab 10 mg/kg had a 90% reduction in new HO lesions compared to placebo.

  • 5

    Adverse reactions in garetosmab-treated patients included abscess, acne, and increased hair growth, among others.

Original Source(s)

FDA approves garetosmab for adults with FOP

  • by Kathryn Wighton

  • August 20, 2026

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