SFDA Becomes First Regulator to Approve Frehemgo for Haemophilia A

The Saudi Food and Drug Authority has become the first regulator globally to approve Frehemgo, or denecimig, for the routine prevention of bleeding episodes in patients with haemophilia A.

The approval covers patients with or without factor VIII inhibitors and follows the drug’s earlier designation under the authority’s Breakthrough Medicine Program, which is intended to accelerate access to specialised treatments.

Frehemgo is a bispecific antibody that mimics the function of activated factor VIII by bridging coagulation factor IXa and factor X on the surface of activated platelets. Its mechanism is designed to work regardless of whether a patient has developed factor VIII inhibitors.

The treatment is administered through subcutaneous injection and can be given once weekly, every two weeks or once monthly, depending on body weight and the treating physician’s assessment.

The authority said approval followed a comprehensive review of efficacy, safety and quality based on the full registration dossier.

Clinical evaluation included four Phase 3 studies covering different severities of haemophilia A and both inhibitor and non-inhibitor populations. The programme included studies involving adults, adolescents and children, an open-label extension across age groups, and a safety study assessing patients switching from emicizumab.

The most commonly reported adverse reactions included injection-site erythema and pruritus, fever, headache and upper respiratory tract infections. Elevated coagulation activation markers, including prothrombin fragment 1+2 and D-dimer, were also observed.