Saudi Arabia’s SFDA has approved Leqembi (lecanemab), the Kingdom’s first Alzheimer’s treatment. This innovative drug slows disease progression by targeting beta-amyloid plaques, protein clumps that disrupt brain cell communication. Approved for patients with mild symptoms and specific genetic profiles, Leqembi requires careful monitoring to manage side effects, marking a major step forward in Alzheimer’s care through advanced biotechnology. The Saudi Food and Drug Authority (SFDA) announced today the official approval of Leqembi, the first Alzheimer’s treatment available in Saudi Arabia. This approval marks a significant milestone in addressing Alzheimer’s, a progressive brain disorder that affects memory and thinking skills. Leqembi is specifically indicated for patients experiencing mild cognitive impairment or mild dementia caused by Alzheimer’s, who have either no copies or just one copy of a particular gene variant known as apolipoprotein E4 (ApoE4). Leqembi represents an innovative approach to treating Alzheimer’s. Unlike many existing therapies that only ease symptoms, this drug aims to slow the actual progression of the disease. It is a biologic therapy developed using monoclonal antibody technology, a sophisticated method that creates lab-produced molecules designed to target specific proteins in the body. In this case, Leqembi works by targeting beta-amyloid proteins, which tend to build up in the brains of Alzheimer’s patients and form sticky clumps called plaques. These plaques are widely believed to contribute to the cognitive decline seen in the disease. Specifically, brain plaques, known as amyloid plaques, are abnormal clumps of protein fragments called beta-amyloid that build up in the brain, especially in people with Alzheimer’s. These plaques interfere with the normal communication between nerve cells (neurons), disrupting brain function. By helping reduce the formation of these harmful plaques, Leqembi seeks to protect brain function and slow cognitive decline over time. The treatment is given through an intravenous infusion every two weeks, allowing the drug to circulate and act within the brain. Before approving Leqembi, the SFDA thoroughly reviewed evidence of its safety, effectiveness, quality, and compliance with regulatory standards. Clinical trials revealed that Leqembi significantly slows the progression of Alzheimer’s disease compared to a placebo. The effectiveness was measured using established clinical scales that assess memory, thinking, and daily functioning abilities. However, like all medications, Leqembi can cause side effects. The most commonly reported include: Headaches; Reactions related to the infusion process; Amyloid-related imaging abnormalities (ARIA), a term that refers to unusual changes detected in brain MRI scans. These abnormalities may include swelling (cerebral edema) or tiny brain bleeds (microhemorrhages). Because ARIA can only be detected through brain scans, careful monitoring is essential throughout treatment. The SFDA stresses the importance of ongoing patient monitoring during treatment. Before starting Leqembi, patients must be tested for their ApoE4 gene status, as this influences the risk of side effects. Those with two copies of the ApoE4 gene are not currently eligible for the treatment due to a higher likelihood of complications. Additionally, the pharmaceutical company responsible for Leqembi is required to track how the drug performs once it is in use (post-marketing surveillance). They must regularly submit updated reports on safety and effectiveness to the SFDA. A comprehensive risk management plan is also mandatory to ensure the treatment is used safely and responsibly. The approval of Leqembi reflects the SFDA’s commitment to expanding access to advanced and high-quality medical treatments, especially those developed through cutting-edge biotechnological methods. Biotech therapies like Leqembi represent a rapidly growing field in medicine, offering new hope for diseases that previously had limited treatment options. Established in 2003 under the Council of Ministers’ resolution, the Saudi Food and Drug Authority is an independent regulatory body directly reporting to the President of the Council of Ministers. Its main mission is to safeguard public health by ensuring the safety and quality of food, medicines, biological and chemical substances, medical devices, and cosmetics. The SFDA oversees all procedures related to these products, aiming to protect both human and animal health throughout the Kingdom.
