The US Food and Drug Administration announced on Friday that it has approved Hympavzi (marstacimab-hncq) for routine prophylaxis in patients 12 years and older with hemophilia A or B, without factor inhibitors.

Pharmaceutical and biotechnology company Pfizer Inc. (NYSE:PFE) received FDA approval along with Orphan Drug designation for Hympavzi.

Hemophilia patients, who lack coagulation factors VIII or IX, experience prolonged bleeding, which can lead to life-threatening spontaneous bleeding. Hympavzi works by reducing the activity of tissue factor pathway inhibitor, increasing thrombin production to prevent or reduce bleeding episodes.

Approval was based on a study showing Hympavzi significantly lowered annualized bleeding rates compared to on-demand factor replacement. Comparable efficacy was observed when compared to prophylactic factor replacement. Hympavzi carries risks of thromboembolic events, hypersensitivity, and embryofetal toxicity.