Saudi FDA First Globally to Approve Frehemgo for Hemophilia A Patients

Saudi Arabia's Food and Drug Authority (SFDA) has approved Frehemgo, also known as denecimig, becoming the first regulatory authority in the world to grant this approval for routine prophylaxis against bleeding episodes in hemophilia A patients, whether or not they have inhibitors to factor VIII, a blood clotting factor.

Hemophilia A is an inherited bleeding disorder caused by deficiency or absence of factor VIII, which puts patients at risk of recurrent bleeding. Prior to approval, the drug received a "breakthrough medicine" designation under the SFDA's breakthrough drug program.

Frehemgo works as a bispecific monoclonal antibody that mimics the function of activated factor VIII, bridging factors IXa and X on the surface of activated platelets, thereby enhancing thrombin generation and improving clotting. Its mechanism of action is notably independent of the presence or absence of factor VIII inhibitors.

The drug is administered via subcutaneous injection once weekly, every two weeks, or once monthly, depending on the patient's weight and the treating physician's judgment.