On November 14, 2024, the European Union's drugs regulator, the Committee for Medicinal Products for Human Use (CHMP), issued a positive opinion recommending the approval of Eisai and Biogen's Alzheimer's drug, Leqembi. This recommendation is for patients with early Alzheimer's disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.
This positive opinion represents a significant reversal from the agency's initial negative stance in July 2024, following a re-examination requested by Biogen and Eisai. The CHMP's decision is based on comprehensive data, including the Phase 3 Clarity AD study, which demonstrated Leqembi's ability to selectively bind to and clear amyloid-beta aggregates, thereby reducing disease progression and slowing cognitive and functional decline.
The European Commission is now expected to make a final decision on the marketing authorization application within 67 days of receiving the CHMP's recommendation. This potential approval would open a substantial market for Leqembi across the EU, where an estimated 6.9 million people are affected by Alzheimer's disease, and would mark a landmark advancement in the treatment of this debilitating condition.
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