Riyadh, Saudi Arabia — In a landmark move, the Saudi Food and Drug Authority (SFDA) has approved using Leqembi Alzheimer’s treatment in the Kingdom. This is the first therapy in Saudi Arabia designed to slow the disease’s progression, not just mask its symptoms.

A New Type of Alzheimer’s Therapy

Leqembi, also known as lecanemab, is a monoclonal antibody therapy developed for patients with mild cognitive impairment or early-stage Alzheimer’s. It is approved for individuals who carry no more than one copy of the ApoE4 gene variant.

The treatment is given every two weeks through intravenous infusion. It targets beta-amyloid plaques in the brain, a key driver of Alzheimer’s. This approach marks a shift in care—from managing symptoms to slowing the disease.

Regulatory Measures and Safety Protocols

SFDA based its decision on strong clinical data. Trials showed Leqembi performed better than placebo treatments. Common side effects include headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA), which may include brain swelling or small bleeds. Patients must undergo regular MRIs during treatment.

To ensure safety, SFDA has imposed strict post-marketing requirements. These include ongoing safety checks and a formal risk management plan. Patients must be tested for ApoE4 status before starting the drug.

These rules highlight the SFDA’s readiness to manage new biotech therapies with care and oversight.

A Step Toward Precision Care

This approval supports Saudi Arabia’s healthcare goals under Vision 2030. It boosts access to biotechnology treatments and supports a move toward precision medicine. It also builds the Kingdom’s ability to offer advanced care for chronic diseases.

With this decision, Saudi Arabia joins a growing number of countries offering Leqembi Alzheimer’s treatment, bringing new hope to patients and families affected by the disease.

 

 

THE SAUDI STANDARD’S VIEW: Leqembi Approval Marks Saudi Milestone in Personalized Healthcare

The SFDA’s approval of Leqembi Alzheimer’s treatment in Saudi Arabia marks a breakthrough for the Kingdom’s healthcare system. It reflects national growth in biotech oversight and patient-centered care.

  • The decision signals a shift in how Saudi Arabia treats Alzheimer’s—embracing drugs that change the disease’s path rather than just ease its symptoms.
  • Requiring genetic testing for ApoE4 sets a precedent for personalized medicine in the Kingdom.
  • SFDA’s approval process, with its safety checks and post-marketing rules, shows Saudi readiness to manage complex biologic treatments.
  • The move aligns with Vision 2030 goals to grow access to advanced therapies and build local strength in health innovation.

Leqembi’s registration is not only a medical first. It also shows Saudi Arabia’s growing confidence and capability in delivering precision care and becoming a regional pharmaceutical science leader.

 

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