Saudi Arabia First to Approve Haemophilia A Drug Frehemgo

The Saudi Food and Drug Authority (SFDA) has approved the registration of Frehemgo (denecimig) for the routine prevention of bleeding episodes in patients with haemophilia A, whether or not they have factor VIII inhibitors. The approval makes Saudi Arabia the first regulatory authority in the world to grant marketing authorization for the therapy for this use.

The medicine had previously been designated under the SFDA's Breakthrough and Promising Medicines Program, a status that speeds up the review of therapies addressing serious conditions. Full registration was granted only after a comprehensive scientific and technical evaluation of the drug's efficacy, safety, and quality. The authority stressed that the earlier Breakthrough designation did not amount to marketing authorization — only the registration announcement represents that.

The review drew on four phase III clinical trials: a study in adults and adolescents, a pediatric study, a long-term study across all age groups, and a study evaluating safety when patients switch from an existing therapy. The approval covers all severities of haemophilia A and applies to patients both with and without factor VIII inhibitors.

Why it matters

Haemophilia A is a lifelong bleeding disorder, and routine long-term prophylaxis aims to prevent and reduce bleeding episodes before they happen. Registering a new preventive therapy expands the options available to patients and their treating physicians in the Kingdom.

As of mid-September 2026, the SFDA's communications describe regulatory registration status only. No Saudi-specific details have yet been published on pricing in Saudi Riyal, hospital or pharmacy dispensing fees, patient co-payment levels, reimbursement rules, or inclusion in national formularies. Patients and caregivers should follow official SFDA channels for further updates.

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