Pfizer Seeks Label Expansion For Hemophilia Drug After Promising Data

Pfizer Inc. (NYSE:PFE) released topline results from the Phase 3 BASIS study evaluating Hympavzi (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors.

Phase 3 BASIS study in patients without inhibitors supported the FDA approval of Hympavzi in October 2024.

The study met the primary endpoint and key secondary bleeding endpoints, demonstrating the superiority of once-weekly subcutaneous Hympavzi in improving key bleeding outcomes compared to on-demand treatment in a patient population where less burdensome treatment approaches are needed.

Also Read: FDA Approves Sanofi’s Hemophilia Drug

The BASIS trial demonstrated that prophylactic treatment with Hympavzi resulted in a statistically significant and clinically relevant reduction in annualized bleeding rate (ABR) of ...