RIYADH — The Saudi Food and Drug Authority (SFDA) has officially approved the registration of lecanemab (Leqembi) for the treatment of patients with early-stage Alzheimer's disease, specifically those with mild cognitive impairment or mild dementia, who carry no copies or just one copy of the ApoE4 gene variant. This marks the first approved Alzheimer's treatment in the Kingdom. In a statement, the SFDA noted that lecanemab is a biologic drug based on monoclonal antibody technology, and is the first biologic therapy licensed for Alzheimer's in Saudi Arabia. The treatment works by targeting amyloid beta protein plaques in the brain, a hallmark of Alzheimer's pathology, thereby helping slow cognitive decline. The drug is administered via intravenous infusion every two weeks. The authority said the approval followed a comprehensive evaluation of the drug's efficacy, safety, and quality, with clinical trials showing that lecanemab slows the progression of symptoms compared to placebo, based on established Alzheimer's disease assessment scales. The most commonly reported side effects included headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA) — brain changes detectable via MRI that may involve brain swelling or microbleeds. The SFDA emphasized the importance of ongoing patient monitoring during treatment, particularly for any emerging side effects. Genetic testing is required before initiating therapy to assess patient eligibility and reduce risk of adverse reactions. The authority also required the manufacturer to submit regular post-marketing reports on the drug's effectiveness and safety, and to implement a risk management plan to ensure the treatment's optimal and safe use.
