Riyadh: The Saudi Food and Drug Authority (SFDA) has approved the registration of Leqembi (lecanemab) for the treatment of patients with mild cognitive impairment or mild dementia due to Alzheimer's disease who carry no copies or only one copy of the apolipoprotein E4 (ApoE4) gene variant. This marks the first Alzheimer's treatment to be approved in Saudi Arabia.
According to Saudi Press Agency, lecanemab is an innovative biologic therapy manufactured using monoclonal antibody technology. It is the first therapy of its kind approved for slowing the progression of Alzheimer's disease, rather than merely alleviating symptoms. The drug works by targeting beta-amyloid proteins that accumulate in the brain, helping reduce the formation of plaques associated with cognitive decline in Alzheimer's patients. The therapy is administered via intravenous infusion every two weeks.
The SFDA approved the drug's registration following a thorough evaluation of its efficacy, safety, quality, and compliance with regulatory standards. Clinical trials demonstrated that lecanemab showed positive results in slowing disease progression compared to a placebo, based on established clinical measures used to assess the effectiveness of Alzheimer's treatments.
The most common side effects included headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA), a general term referring to abnormal changes in brain MRI scans associated with the treatment. These include cerebral edema or microhemorrhages and are detectable through brain imaging.
The SFDA emphasized the need for regular monitoring of patients during the course of treatment, particularly for tracking side effects. It also stressed the importance of evaluating the patient's genetic profile (ApoE4 status) prior to initiating therapy to reduce the likelihood of adverse effects.
The authority required the company to monitor post-marketing data and submit updated periodic reports regarding the drug's efficacy and safety. Furthermore, a risk management plan must be implemented to ensure the optimal and safe use of the treatment.
The registration of this therapy is part of the SFDA's ongoing efforts to enhance access to high-quality treatment options in Saudi Arabia, especially those developed through biotechnological applications, which are witnessing rapid scientific advancement.