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FDA Grants Priority Review for Pfizer’s HYMPAVZI

Submission aims to expand HYMPAVZI indication to the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients without inhibitors.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Pfizer’s supplemental Biologics License Application (sBLA) for HYMPAVZI (marstacimab) to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. In the U.S., HYMPAVZI is currently approved for the treatment of patients 12 years of age and older with hemophilia A...

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