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Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the approval of Eisai Co., Ltd (OTC:ESALY) (OTC:ESALF) and Biogen Inc.’s (NASDAQ:BIIB) lecanemab. The companies seek approval for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody as a treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD). 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 ...