On 11 January, Eisai announced the submission of a marketing authorisation application (MAA) for Lecanemab to the European Medicines Agency (EMA). Lecanemab, an anti-amyloid antibody that clears amyloid plaques from the brain, was recently approved for the treatment of early Alzheimer’s disease (AD) by the US Food and Drug Administration. Eisai’s application to the EMA is based on the results of two clinical trials; a Phase 2b study that enrolled 854 participants, and the Phase 3 CLARITY-AD study, which evaluated the efficacy of Lecanemab in 1,795 participants. Both of these studies were focused on mild cognitive impairment and mild dementia due to Alzheimer’s disease, with results that showed a substantial reduction in brain amyloid levels, accompanied by a slowing of clinical decline after 18 months of intravenous, biweekly Lecanemab treatment.
In their joint press release, Eisai and Biogen stated that the MAA for Lecanemab was submitted for the treatment of early AD, defined as mild cognitive impairment and mild AD dementia. If the EMA accepts the MAA for review, the centralised assessment procedure may be completed within a year; the accelerated assessment procedure is slightly shorter, at 150 “active” days compared to 210 days with the centralised procedure.