The U.S. Food and Drug Administration has approved a drug from Pfizer for preventing or reducing the frequency of bleeding episodes in children and certain hemophilia patients, the company announced on Monday.

This clearance makes Pfizer's drug, Hympavzi, the first non-factor therapy available for children aged 6 to 11 with hemophilia B, irrespective of whether they have inhibitors.

The regulatory body also expanded the approved use to include patients aged 12 and older with inhibitors, which are antibodies, for both hemophilia A and B.

Hympavzi had previously received approval for patients aged 12 and older who have not developed antibodies that interfere with the function of clotting proteins.

The medication is administered subcutaneously via an auto-injector pen, offering an alternative to intravenous therapies that often require multiple infusions per week.

Hemophilia is a rare disorder where individuals lack sufficient clotting proteins, known as clotting factors, making it difficult for their blood to clot and leading to spontaneous severe bleeding following injury or surgery.

Hemophilia A, the most common form, is caused by a deficiency or low levels of clotting factor VIII, while hemophilia B results from a deficiency or low levels of clotting factor IX.

In a late-stage clinical trial, Hympavzi demonstrated a significant reduction in the average annualized bleeding rate for adults and adolescents aged 12 and older with hemophilia A or B who also had inhibitors.