Approval of Leqembi in early Alzheimer’s disease rejected by CHMP
Japan’s Eisai (TYO: 4523) and US biotech Biogen (Nasdaq: BIIB) today that announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).
The Tokyo stock exchange was closed by the time of the announcement, but Biogen's shares fell 6.3% to $213.08 in US pre-market trading.
The EMA’s statement explained that the committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi.
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