Saudi Arabia Approves Groundbreaking Alzheimer’s Drug Leqembi: A Regional First

ARTICLES

Dr. Islam Sharqeyeh

7/30/20252 min read

Saudi Arabia has officially approved Leqembi (generic name: lecanemab), becoming the first country in the Middle East to register a disease-modifying therapy for Alzheimer’s disease. The Saudi Food and Drug Authority (SFDA) announced its authorization of the drug on July 29, 2025, marking a major milestone in the region's battle against neurodegenerative diseases.

🧠 What Is Leqembi?

Leqembi is a monoclonal antibody therapy developed by Eisai and Biogen. It targets the amyloid-β plaques that accumulate in the brains of patients with Alzheimer’s disease, believed to be a key driver of disease progression. Unlike symptomatic treatments, Leqembi is designed to slow the progression of Alzheimer’s in its early stages.

✅ Approved Indications

  • Patients with early-stage Alzheimer’s disease

  • Individuals diagnosed with mild cognitive impairment (MCI) due to Alzheimer’s

  • Those who test negative or have a single copy of the ApoE4 gene

⏱ Dosage & Administration

  • Intravenous infusion every two weeks

  • Administered under clinical supervision, with regular imaging and genetic monitoring

⚠️ Safety Profile and Monitoring

While Leqembi offers hope, it also presents clinical risks requiring careful oversight:

  • Common side effects: Headaches, infusion reactions, and amyloid-related imaging abnormalities (ARIA) such as brain swelling or small hemorrhages.

  • Mandatory MRI monitoring: Patients are typically required to undergo brain imaging at multiple intervals to screen for ARIA.

  • Genetic screening: Testing for the ApoE4 allele is required, as patients with two copies face a higher risk of serious complications.

To ensure safe administration, the SFDA mandates a post-marketing risk management plan and regular real-world safety data submissions from the manufacturer.

🏥 Saudi Arabia’s Strategic Commitment to Alzheimer’s Care

The approval of Leqembi aligns with Saudi Arabia’s Vision 2030 and its national healthcare strategy to embrace precision medicine and biotechnology innovation.

To support implementation:

  • King Faisal Specialist Hospital and Research Centre (KFSHRC) has partnered with Eli Lilly to establish a regional center of excellence for Alzheimer’s care and research.

  • The partnership includes local production of PET scan radiopharmaceuticals, advanced training programs for clinicians, and enhanced diagnostic capabilities across the Kingdom.

This initiative positions Saudi Arabia as a regional hub for neurodegenerative disease management and innovation.

🧪 Is Leqembi a Cure?

No, Leqembi is not a cure. It does not reverse damage already done by Alzheimer’s. Instead, it slows the cognitive decline in carefully selected patients during early disease stages.

International clinical trials (e.g., CLARITY-AD) have shown that lecanemab can slow decline by 27% over 18 months, though benefits vary across populations.

🇸🇦 Considerations for Use in the Gulf Region

Leading Saudi neurologists and researchers emphasize the importance of infrastructure readiness:

  • Multidisciplinary memory clinics (neurology, geriatrics, psychiatry)

  • Availability of genetic and CSF biomarker testing

  • Standardized cognitive assessments in Arabic

  • Access to PET imaging and MRI monitoring

Without this ecosystem, safe and equitable delivery of Leqembi may be limited.

🔍 Final Thoughts

The approval of Leqembi by the SFDA is a historic leap forward for Alzheimer’s care in the Arab world. It brings hope to thousands of families affected by this devastating illness.

However, it also raises urgent questions:

  • Who will have access?

  • Will the cost be covered by insurance?

  • How will rural or low-resource areas adapt?

The answers will unfold as Saudi Arabia embarks on this new frontier of neurotherapeutics, potentially inspiring other countries in the region to follow suit.