The Food and Drug Administration on Thursday granted full approval to the first therapy for Alzheimer’s disease clearly shown to slow the cognitive decline associated with the disease — a milestone in treatment, even if the benefits are modest.
The drug, called Leqembi, was developed by Eisai, the Japanese pharmaceutical company, and sold in partnership with Biogen. It previously secured conditional approval in January. The FDA’s decision will broaden patient access to the drug under the Medicare program and is likely to boost sales, even as Leqembi’s benefits and safety risks continue to be a source of debate.
Leqembi’s full, or traditional, approval was supported by results of a large clinical trial in which the drug slowed the rate of cognitive and functional decline by 27% compared to a placebo. Leqembi also beat placebo on a series of secondary measures of Alzheimer’s, and it had a dramatic effect on clearing toxic brain plaques called beta-amyloid, which play a role in the progression of the disease.