FDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need

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• If approved, HYMPAVZI would become the first non-factor prophylactic treatment available for children aged 6 to 11 years with hemophilia B

  80% confidence

• HYMPAVZI has the potential to become a transformative option for patients with limited or burdensome treatment options

  80% confidence

• There is a significant medical need for younger patients with hemophilia and for those who have developed inhibitors

  80% confidence

• Treatment approaches that prevent bleeds are particularly important to protect growing joints in children ages 6 to 11 with hemophilia

  80% confidence

• HYMPAVZI was discovered by Pfizer scientists and has a unique mechanism of action differentiated from factor VIII and IX replacement treatments

  80% confidence

• HYMPAVZI would address a critical unmet medical need for pediatric patients ages 6 to 11 with hemophilia B who do not have non-factor treatment options available

  80% confidence

• HYMPAVZI offers a combination of bleed protection with straightforward, once-weekly subcutaneous injection administration, requiring minimal preparation and no routine treatment-related lab monitoring

  80% confidence

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