Lecanemab Approved for Early Alzheimer’s Treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has officially approved a product licence for the medicine lecanemab, also known as Leqembi, for use in the early stages of Alzheimer’s disease as of 22 August 2024.

Lecanemab is notable for being the first treatment licensed in Great Britain that demonstrates potential effectiveness in slowing the progression of Alzheimer’s disease. This significant decision follows an extensive review of the benefits and risks associated with the medication.

Julian Beach, the Interim Executive Director of Healthcare Quality and Access at the MHRA, emphasized the agency’s commitment to licensing medicines that meet acceptable safety, quality, and efficacy standards. He assured that the regulatory standards for lecanemab have been thoroughly met.

The approval targets adults in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 gene, commonly referred to as ApoE4. Approximately 15% of diagnosed Alzheimer’s patients have two copies of this gene, which increases their risk of developing the disease.

In a main clinical trial involving 1,795 participants diagnosed with early Alzheimer’s disease, it was observed that ApoE4 homozygous patients faced a higher risk of developing Amyloid Related Imaging Abnormalities (ARIAs) when treated with lecanemab compared to those with one or no copies of the gene. Many ARIA incidents were asymptomatic, but serious symptoms did occur in a small number of patients.

The Commission on Human Medicines (CHM) advised that while the risk-benefit ratio of lecanemab is favorable for ApoE4 non-carriers and heterozygous patients, it is less favorable for those in the homozygous group. Therefore, gene testing for ApoE4 is necessary prior to initiating treatment.

Contraindications for lecanemab include patients on anticoagulants or those diagnosed with cerebral amyloid angiopathy (CAA), as risks in these cases outweigh potential benefits.

Lecanemab is a monoclonal antibody that binds to amyloid beta protein, which forms plaques in the brains of Alzheimer’s patients. By reducing these clumps, lecanemab aims to slow disease progression.

The medication is administered intravenously every two weeks in a healthcare setting, with treatment continuing as long as the patient remains in the mild Alzheimer’s stage.

In the clinical trial, lecanemab demonstrated a statistically significant reduction in cognitive decline and amyloid beta plaque levels in patients compared to the placebo group.

The most commonly reported side effects include infusion-related reactions, headaches, and ARIA. The MHRA will conduct ongoing reviews of the medication’s safety and effectiveness.

To ensure the safe use of lecanemab, a central registration system will be instituted as part of a controlled access program. There will also be a controlled post-authorisation safety study focusing on the incidence and severity of ARIAs and long-term safety outcomes.

Patients experiencing side effects from the medication are encouraged to consult their healthcare provider and report issues through the Yellow Card scheme.