Biogen & Partner Eisai Get EU Nod for Alzheimer's Drug Leqembi [Yahoo! Finance]
Biogen Inc. (BIIB)
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Source: Yahoo! Finance
The regulatory body has approved Leqembi as a treatment for adult patients with early AD who are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes with confirmed amyloid pathology in Europe. Biogen's partner, Japan-based Eisai, leads the clinical development and regulatory submissions for Leqembi. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority. Year to date, shares of Biogen have plunged 23.5% compared with the industry's decline of 6.5%. Image Source: Zacks Investment Research The approval for Leqembi in the EU is a positive for Biogen and Eisai, as it comes after several hurdles that delayed the approval timeline of the drug. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had given a negative opinion regarding the marketing approval of Leqembi for early AD in July 2024. Although patients given Leqembi had lower CDR-SB scores than those given placebo, the
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BIIB
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