On Friday, a US Food and Drug Administration (FDA) panel voted unanimously in support of giving full approval to Leqembi, an Alzheimer's drug made by Eisai and Biogen that received accelerated FDA approval in January.
The six-member panel reportedly agreed that a late-stage study of the drug's effectiveness shows it was beneficial in slowing cognitive decline by 27% in people with mild cognitive impairment or mild Alzheimer's dementia.
Leqembi carries significant life-threatening risks, including brain swelling and cerebral hemorrhages, and is expected to cost Medicare up to $5B a year. If the drug is approved, the only beneficiary would be US insurance companies and its manufacturers, Eisai and Biogen — as Leqembi sales are expected to top $1B in 2026 and reach $5.7B by 2030.
This is a historic step forward for nearly 6M Americans whose lives are disrupted due to Alzheimer's and are often prevented from accessing much-needed treatment. Since its benefit outweighs the risks, the FDA must approve Leqembi considering the burden of the disease on caregivers and the progressive nature of the disease.
There's a 24% chance that the efficacy of a new Alzheimer's treatment protocol will be confirmed by January 2025, according to the Metaculus prediction community.