The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. It’s the first medicine that’s been convincingly shown to modestly slow Alzheimer’s cognitive decline.
This image provided by Eisai in January 2023 shows vials and packaging for their medication, Leqembi. On Thursday, July 6, 2023, U.S. officials granted full approval to the closely watched Alzheimer’s drug.
The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” said FDA’s neurology drug director, Teresa Buracchio, in a statement.
There were concerns that the cost of new plaque-targeting Alzheimer’s drugs like Leqembi could overwhelm the program’s finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year’s supply of IVs every two weeks. Medicare recipients getting Leqembi must be enrolled in a federal registry to track the drug’s real-world safety and effectiveness. The information will help advance “knowledge of how these drugs can potentially help people,” Medicare officials said.
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