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FDA Approves Alzheimer’s Drug Leqembi

The drug slows the progression of Alzheimer’s, but comes with a severe box warning about potentially lethal side effects.

Leqembi
leqembi

An NBC News article noted the FDA’s recent clearance of the Alzheimer's drug Leqembi, the first of its kind to receive full regulatory approval. However, it comes with a strong safety warning about potentially life-threatening side effects. Leqembi, developed by Japanese drugmaker Eisai and U.S.-based Biogen, targets beta-amyloid, a protein believed to be an underlying cause of Alzheimer's. In a phase 3 clinical trial, the drug demonstrated a 27% slowing of disease progression over 18 months. 

Though Leqembi doesn’t cure or stop the disease, it does provide patients more time for independent living and a better quality of life. However, some experts have expressed concerns about the drug's benefits, noting that the 27% slowing of disease progression may not be noticeable to patients. The FDA has included an aggressive boxed warning about potential side effects, including brain swelling and hemorrhage that can lead to seizures and death. Leqembi is approved for people with mild cognitive impairment or early-stage Alzheimer's disease, and costs a cool $26,500 per year.

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