Innovation

FDA Approves Promising New Alzheimer’s Drug Leqembi

BIG STEPS

It is the first Alzheimer’s antibody treatment to get full FDA approval and to be broadly covered by Medicare.

Alzheimer's drug Leqembi was approved by the FDA Thursday, the same day that Medicare pledged to cover it.
EISAI/Handout via REUTERS / Reuters

The Food and Drug Administration approved the early Alzheimer’s treatment Lequembi on Thursday—a critical step in making the expensive drug more accessible to American seniors. Not only is it the first Alzheimer’s antibody treatment to get full FDA approval, it’s also the first that will be broadly covered by Medicare. Leqembi is notoriously expensive, with a more than $26,000 yearly cost, making its Medicare coverage crucial. Alzheimer’s is the sixth leading cause of death in the United States, according to the FDA, and Leqembi has been shown to modestly slow cognitive decline from the disease. During the drugmaker’s clinical trial, Leqembi slowed cognitive decline in early Alzheimer’s patients by 27% over 18 months. It also carries some serious risks, including swelling and bleeding of the brain. Three participants in the clinical trial died, but FDA scientists said it’s unclear whether Leqembi was to blame.

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