The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended lecanemab for the treatment of Alzheimer’s disease (AD) in adults experiencing mild cognitive impairment and mild dementia. This decision follows a re-examination of a prior negative opinion and is based on positive results from the late-stage Clarity AD trial, marking a significant step forward in addressing early-stage AD.
The CHMP specifically recommends lecanemab for patients with one or no copies of the apolipoprotein E4 gene. The recommendation is rooted in data from the Clarity AD trial, a global study where lecanemab demonstrated a 31% reduction in clinical decline over 18 months compared to placebo. This decline was measured using the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a tool assessing cognitive and functional abilities across six domains, including memory, orientation, judgment, problem-solving, community affairs, home and hobbies, and personal care.
Eisai, leading the development and regulatory submissions for lecanemab, requested the re-examination that led to this positive recommendation. The European Commission will now review the CHMP’s recommendation to make a final decision regarding the approval of lecanemab for early AD in Europe. Alzheimer's disease affects an estimated 6.9 million people in Europe, progressively impairing memory, thinking skills, and the ability to perform simple tasks.
Lecanemab, administered intravenously, functions by binding to and reducing amyloid beta protein clumps that form plaques in the brain, a hallmark of Alzheimer’s disease. This mechanism of action aims to slow the progression of the disease by targeting its underlying pathology.
While the CHMP’s decision marks progress, challenges remain. In the UK, lecanemab received approval from the Medicines and Healthcare products Regulatory Agency but was not recommended by the National Institute of Health and Care Excellence (NICE) for use on the NHS in England and Wales. NICE cited that the drug’s benefits were “too small to justify the costs.”
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, described the news as “bittersweet,” highlighting the scientific achievement of developing treatments that slow the effects of Alzheimer’s but also noting the healthcare system's preparedness to adopt these new therapies.
