SFDA becomes first global regulator to approve Frehemgo for Hemophilia A bleeding prevention

RIYADH — The Saudi Food and Drug Authority (SFDA) has become the first regulatory body globally to approve the registration of Frehemgo (denecimig) for the routine prophylaxis of bleeding episodes in patients with hemophilia A, with or without factor VIII (FVIII) inhibitors. Hemophilia A is an inherited bleeding disorder caused by a deficiency or absence of FVIII, a protein essential for normal blood clotting, leaving patients at increased risk of recurrent bleeding. Before its approval, FREHEMGO was designated under the SFDA’s Breakthrough Medicine Program, part of the authority’s efforts to expedite patient access to specialized treatments in Saudi Arabia. Frehemgo is a bispecific antibody that mimics the function ofactivated FVIII by bridging coagulation factor IXa (FIXa) and factor X (FX) on the surface of activated platelets. This promotes thrombin generation and enhances coagulation to help prevent bleeding. Its mechanism of action is independent of the presence or absence of FVIII inhibitors. Frehemgo is administered by subcutaneous injection once weekly, every two weeks, or once monthly, depending on the patient’s body weight and the physician’s assessment. The SFDA stated that the approval followed a comprehensiveassessment of efficacy, safety, and quality based on the totality of evidence submitted in the registration dossier. The efficacy and safety of denecimig were evaluated in participants with all severities of hemophilia A, with or without FVIII inhibitors, across four Phase 3 studies: one involving adults and adolescents, another involving pediatric patients, an open-label extension study involving all age groups, and a safety-only study evaluating the switch from emicizumab in adults and adolescents. Clinical studies showed that the most commonly reported adverse reactions included injection-site reactions, such as erythema and pruritus, pyrexia, headache, and upper respiratory tract infections. Elevated levels of laboratory markers of coagulation activation, including prothrombin fragment 1+2 and D-dimer, were also observed.