FDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need
View original at finance.yahoo.comFDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need Submission is to expand HYMPAVZI indication to the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) wit…
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There is a significant medical need for younger patients with hemophilia and for those who have developed inhibitors
80% confidenceTreatment approaches that prevent bleeds are particularly important to protect growing joints in children ages 6 to 11 with hemophilia
80% confidenceHYMPAVZI has the potential to become a transformative option for patients with limited or burdensome treatment options
80% confidenceIf approved, HYMPAVZI would become the first non-factor prophylactic treatment available for children aged 6 to 11 years with hemophilia B
80% confidenceHYMPAVZI was discovered by Pfizer scientists and has a unique mechanism of action differentiated from factor VIII and IX replacement treatments
80% confidenceHYMPAVZI offers a combination of bleed protection with straightforward, once-weekly subcutaneous injection administration, requiring minimal preparation and no routine treatment-related lab monitoring
80% confidenceHYMPAVZI 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