The Food and Drug Administration approved Leqembi, an injection-based drug to slow the onset of Alzheimer’s disease, on July 6. It is the first drug approved by the FDA to decelerate the symptoms of Alzheimer's, including memory loss, confusion, problems with speaking or writing and changes in mood.
According to the Alzheimer’s Association, around 6.7 million Americans above age 65 are living with the disease, almost two-thirds of whom are women. One out of three seniors in the U.S. will die with Alzheimer’s or another form of dementia and deaths from Alzheimer's have more than doubled since 2000.
Leqembi will be available to those diagnosed with early forms of Alzheimer’s. This constitutes roughly 17% of those living with the disease today. In an FDA-reviewed study, the drug was shown to reduce declines in cognitive ability by 27% over 18 months.
The drug targets a protein in the brain called beta-amyloid, which is believed to play a large role in Alzheimer’s onset. Due to consistent data showing the drug successfully removed beta-amyloids from the brain, the drug received an accelerated approval by the FDA in January 2022.
While Leqembi is now fully approved for use outside of clinical trials, several infrastructural problems for the drug will need to be solved to guarantee universal access. The drug requires an initial test to determine amyloid levels in the brain, regular injections and brain scans to detect dangerous side effects, something not many specialists have received training in. Some users may receive side effects including headache, fever, and in a small percentage of cases, swelling and bleeding in the brain, which routine scans will test for.
Leqembi will cost $26,500 annually for patients. Due to FDA approval, the drug will be available at reduced cost to those covered by Medicare, but out-of-pocket costs could still be more than $5,000/year.