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The Saudi Food and Drug Authority granted registration to Frehemgo, also known by its generic name denecimig, for use in routine prophylaxis to prevent bleeding episodes among patients with haemophilia A. The authority announced the decision on September 14, 2026, after completing a full scientific evaluation of the submitted dossier covering efficacy, safety and quality standards. According to the SFDA, the medicine applies to all severities of the condition and to patients both with and without factor VIII inhibitors. The approval marks the first time any regulator has cleared the therapy for market use anywhere in the world.
World Federation of Haemophilia figures from its 2025 global survey placed the number of identified haemophilia A patients in Saudi Arabia at 1,281. Studies of bleeding disorders in the kingdom have noted higher prevalence linked to patterns of consanguineous marriage that increase the likelihood of inherited conditions, a Saudi research team reported in a 2022 analysis published in the Journal of Applied Hematology. The SFDA had granted the product breakthrough medicine status in May 2026 to accelerate review of treatments for serious conditions where current options fall short.
Frehemgo is a bispecific antibody designed to mimic the function of activated factor VIII in the clotting cascade. It bridges activated coagulation factor IX and factor X on the surface of platelets to stimulate thrombin generation and restore haemostasis, the SFDA assessment found. This mechanism operates regardless of whether factor VIII inhibitors are present in the patient, offering an advantage over some existing replacement therapies.
The medicine is delivered by subcutaneous injection using a pre-filled pen, with dosing intervals of once weekly, every two weeks or once monthly calibrated to the patient’s body weight and the prescribing physician’s evaluation. The SFDA based its registration on results from four phase 3 trials within the FRONTIER clinical programme conducted by Novo Nordisk. Those studies enrolled adults, adolescents and children with all severities of haemophilia A, including an open-label extension and a switch study from emicizumab.
Novo Nordisk had submitted the registration application following positive interim data from the FRONTIER2 and FRONTIER4 trials that demonstrated substantial reductions in annualised bleeding rates compared with on-demand treatment or prior prophylaxis regimens. The company reported that the majority of participants experienced zero treated bleeds during the evaluation periods, with the therapy generally well tolerated and no thromboembolic events recorded. Saudi Arabia’s regulatory action precedes reviews underway at other agencies, including the US Food and Drug Administration that received a biologics license application for the same product in September 2025.
The SFDA noted that Frehemgo originated from a partnership between Novo Nordisk and Genmab, with the bispecific platform offering a next-generation prophylactic option for a rare disorder that requires lifelong management. Haemophilia treatment centres across the kingdom are expected to incorporate the new therapy into protocols once supply channels are established, building on existing haemophilia care infrastructure that has expanded under national health transformation initiatives. Data from the supporting trials remain under continued analysis by the manufacturer for presentation at upcoming medical congresses.
