The FDA has approved Leqembi (Lecanemab) for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. Approval followed a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. In studies reviewed by the FDA, Leqembi appeared to slow declines in memory and thinking by about 27% after 18 months of treatment. Medicare coverage is significant because the drug is projected to cost about $26,500 per year.
The FDA’s acting director of the Office of Neuroscience in its Center for Drug Evaluation and Research said:
Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.
Other approved treatments include:
- Aducanumab (Aduhelm): approved for individuals with mild cognitive impairment.
- Donepezil (Aricept)
- Rivastogmine (Exelon)
- Galantamine (Razadyne)
- Memantine (Namenda)
- Namzaric
- Suvorexant
