FDA Expands Marstacimab Indication in Hemophilia A and B - Takeaways - MDSpire

FDA Expands Marstacimab Indication in Hemophilia A and B

Phase 3 BASIS and BASIS KIDS data supported the expanded indication across pediatric and inhibitor populations.

  • By

  • Kathryn Wighton

  • June 8, 2026

  • 3 min

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  • 1

    The FDA approved marstacimab-hncq (HYMPAVZI) for routine prophylaxis in hemophilia A and B patients aged 6 years and older.

  • 2

    HYMPAVZI is the first subcutaneous non-factor therapy for pediatric patients aged 6 to 11 years with hemophilia B.

  • 3

    In the phase 3 BASIS trial, marstacimab reduced the mean annualized bleeding rate by 93% compared to on-demand intravenous treatment.

  • 4

    Marstacimab targets the Kunitz 2 domain of tissue factor pathway inhibitor to restore balance between bleeding and coagulation.

  • 5

    Common adverse reactions include injection-site reactions, headache, and pyrexia, with warnings for thromboembolic events and hypersensitivity.

Original Source(s)

FDA Expands Marstacimab Indication in Hemophilia A and B

  • by Kathryn Wighton

  • June 8, 2026

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