Japan’s Eisai (TYO: 4523) and US biotechnology company Biogen (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the Marketing Authorization (MAA) of Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid beta (Aβ) monoclonal antibody, for the treatment of early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).
The Tokyo Stock Exchange was closed at the time of the announcement, but Biogen’s shares fell 6.3% to $213.08 in premarket trading on November 14th (US time).
The EMA statement explained that the committee determined that the observed effects of Leqembi in slowing cognitive decline do not offset the risk of serious side effects associated with the drug, in particular the frequent risk of amyloid-related imaging abnormalities (ARIA), which include potential swelling and bleeding in the brain in patients receiving Leqembi.
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