CHMP Approves Lecanemab for Early Alzheimer's Disease Use
Eisai Europe and Biogen received encouraging feedback for monoclonal antibody therapy for early Alzheimer's disease in adults
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has given a positive opinion to Eisai Europe and Biogen regarding the use of the amyloid-beta (Ab) monoclonal antibody (mAb) lecanemab. This treatment is intended for adult patients who have a clinical diagnosis of mild cognitive impairment and mild dementia caused by Alzheimer’s disease (early AD). Eisai announced CHMP’s decision, which was mainly based on data from a global Phase III clinical trial, in a press release on November 15, 2024.
Patients in the European Union (EU), who will be eligible for treatment once the European Commission has made its final decision on the treatment, would be those who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. ApoE is a protein that is involved in the metabolism of fats in humans and has been identified as the strongest genetic risk factor for sporadic AD and an important biomarker to determine disease susceptibility.
“The positive CHMP opinion moves us closer to providing a potential treatment option that addresses an underlying cause of AD to eligible patients in the EU for the first time,” stated Gary Hendler, regional chairman and CEO, Eisai EMEA, senior vice-president and global corporate officer, Eisai Co. Ltd, Tokyo, in the press release. “AD is a progressive neurodegenerative disease that poses significant challenges to human health and wider society—the loss of someone’s memory and independence can have a significant impact on not only those living with the disease, but also their family and friends. Eisai is committed to making a meaningful difference to all those affected by AD, and we are pleased that our ongoing work with the CHMP is helping to make this available to eligible patients in the EU.”
The opinion from CHMP has been forwarded to the European Commission for a final review. A decision regarding the marketing authorization application is anticipated within 67 days of receiving the opinion. Lecanemab has received approval in the United States, China, Japan, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain, and is currently being reviewed in 17 other countries.
“The positive CHMP opinion is an important milestone and acknowledges the potential of this medicine to benefit eligible individuals and their families affected by this disease.” Wolfram Schmidt, president and head of Europe at Biogen, expressed enthusiasm in the press release, stating, “We look forward to the EC’s decision and are pleased to be one step closer to offering this medicine in the EU.” “Our company is committed to advancing research and treatment for Alzheimer’s disease, focusing on meeting the essential needs in this challenging condition.”
Lecanemab, also known as Leqembi, is a type of humanized antibody that specifically attaches to certain forms of amyloid beta aggregates, including both soluble protofibrils and insoluble fibril aggregates. Research shows that lowering Ab protofibrils might help slow down the progression of AD.
