Breaking: FDA clears second Alzheimer's drug in 'foundational spark' for field
US regulators approved Eisai and Biogen’s Alzheimer’s drug lecanemab, a landmark moment for the disease and a second chance for the companies after their drug Aduhelm was a commercial flop in the face of cost and efficacy concerns.
The FDA cleared the monoclonal antibody under its accelerated approval pathway, for use in patients with mild cognitive impairment from Alzheimer’s who have confirmed presence of amyloid beta pathology prior to treatment, essentially the same population in clinical trials. Like Aduhelm, which the companies brought to market in June 2021, it claims to slow the progression of the neurodegenerative disease. Eisai will sell the drug as Leqembi.
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