The FDA’s decision comes after clinical trial results indicated that lecanemab slows cognitive decline somewhat in people with mild impairment from Alzheimer’s.
The decision on lecanameb comes after Congress issued a scathing report last week about how the FDA handled the controversial approval of another Alzheimer's drug developed by Biogen and Eisai, called Aduhelm. The 2021 approval of that treatment, which experts said did not show a clear clinical benefit, was"rife with irregularities," according to the report.
The FDA approved lecanemab based on the reduction of amyloid plaque observed in clinical trial participants who received the treatment, according to a statement from the agency. Participants who did not receive the treatment, the placebo arm, had no reduction in amyloid plaque., found that cognitive decline was 27% slower over 18 months in people who received lecanemab compared with those who did not receive the treatment. The study was funded by Biogen and Eisai.
Nearly 1,800 people ages 50 to 90 years old with early Alzheimer's participated in the trial, about half of whom received lecanemab and half of whom did not.Though lecanemab may slow cognitive decline somewhat, the treatment also carries risks. About 17% of those who received lecanemab had brain bleeding, compared with 9% in the group that did not take the treatment. The most common symptoms associated with the bleeding was dizziness.
The FDA said the prescribing information for lecanemab will include a warning about a risk of swelling and bleeding, broadly referred to as amyloid-related imaging abnormalities.
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