Pfizer, Inc. (PFE) announced Monday that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HYMPAVZI (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors.
HYMPAVZI is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A with or without factor VIII inhibitors, or hemophilia B with or without factor IX inhibitors.
HYMPAVZI offers a combination of prophylactic bleed protection with a straightforward, once-weekly subcutaneous administration that does not require routine treatment-related lab monitoring.
Results from the Phase 3 BASIS trial (NCT03938792) supported the approval of HYMPAVZI in adults and adolescents 12 years and older with hemophilia A or B with inhibitors.
The results demonstrated the superiority of HYMPAVZI in improving key bleeding outcomes including significantly reducing mean treated annualized bleeding rate (ABR) by 93% compared to on-demand (OD) intravenous treatment with bypassing agents.
Meanwhile, interim results from the Phase 3 BASIS KIDS trial (NCT05611801) supported the approval of HYMPAVZI in children ages 6 to 17 years with hemophilia A or B with or without inhibitors.
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