The European Commission (EC) has granted a marketing authorization for Leqembi®∇ (lecanemab) as the first therapy in the EU targeting an underlying cause of Alzheimer’s.
Eisai Co., Ltd. and Biogen Inc.’s amyloid-beta (Aβ) monoclonal antibody is indicated for adults with mild cognitive impairment and mild dementia due to Alzheimer’s who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology.
The Committee for Medicinal Products for Human Use (CHMP) had originally recommended against a marketing authorisation for Leqembi (lecanemab) in July 2024). However, the EC’s new decision marks a positive shift for the Alzheimer’s treatment landscape. Their approval is based on data from the CLARITY AD Phase III clinical trial.
For example, primary endpoint results showed that lecanemab reduced clinical decline on the clinical dementia rating (CDR)-sum of boxes (SB) scale by 31 percent at 18 months compared to placebo.
Impact of lecanemab’s EU approval in Alzheimer’s
“[The European Commission’s approval is] a landmark advancement in a field where there has been no or little innovation in the past 20 years”
“The approval of lecanemab by the European Commission marks the thirteenth approval of this important medicine,” stated Christopher Viehbacher, President and Chief Executive Officer at Biogen. “Lecanemab is the first treatment which showed that the reduction of the Aβ plaques in the brain is associated with the slowing of cognitive decline in patients at the early stage of the disease. This is a landmark advancement in a field where there has been no or little innovation in the past 20 years.”
“The emergence of new Alzheimer’s disease therapies [in recent years] has demonstrated that we are increasingly capable of treating a condition once deemed untreatable, and the next step in this endeavour is to develop a therapeutic that is both safe and effective,” shared Dr Nataliya Agafonova, Chief Medical Officer at Longeveron Inc., in 2024, following the presentation of new data for the company’s Alzheimer’s cell therapy.
Eisai is leading the global development and regulatory submissions for lecanemab.
∇: This medicinal product is subject to additional monitoring.
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