FDA Panel Backs First Alzheimer's-Modifying Drug
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.
Facts
- 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.1
- 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.2
- The health experts based their decision on the study's data that showed the drug improved people's cognitive functions, including their ability to perform daily tasks, such as dressing and feeding themselves.2
- According to the Alzheimer's Association, as Leqembi changes the course of the disease — unlike current treatments that only treat symptoms — it can help people "live independently."3
- While the recommendation isn't binding, the 6-0 vote could weigh heavily on the FDA's final decision — which it expects to make by July 6 — to make Leqembi the first Alzheimer's-modifying drug to achieve regulatory approval.4
- The FDA's full approval will likely expand Medicare coverage of Leqembi, priced at $26.5K-a-year, for millions of Americans suffering from the brain disorder.2
Sources: 1KUSA, 2Time, 3Alzheimer's Disease and Dementia, and 4ETHealthworld.
Narratives
- Narrative A, as provided by CNBC. 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.
- Narrative B, as provided by Time. 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.
