Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 years and older with hemophilia A or B without inhibitors. This approval aims to prevent or reduce the frequency of bleeding episodes.
HYMPAVZI is notable as the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for hemophilia A or B. It is also the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, once-weekly auto-injector pen, offering a convenient subcutaneous treatment option.
The approval is supported by results from the Phase 3 BASIS trial, where HYMPAVZI reduced the annualized bleeding rate for treated bleeds by 35% compared to routine prophylaxis and 92% compared to on-demand treatment. This marks a significant advancement in care for the more than 800,000 people globally impacted by hemophilia.
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