A Word from Our CEO – FDA Approval of Leqembi
Last Friday, the Food and Drug Administration approved a new treatment for early Alzheimer’s disease. The drug, which will be marketed under the name Leqembi (pronounced le-KEM-bee), may slow cognitive decline in the early stages of Alzheimer’s disease.
The scientific name for this medication is lecanemab, and it’s a drug we’ve studied and tested at Charter Research. In fact, our two research centers are working on Phase 3 clinical trials of lecanemab (Leqembi) now.
The FDA’s approval is an “accelerated approval.” This means that the FDA has approved this drug – with more research required – because it meets two criteria. First, it treats a serious disease for which there aren’t any good treatment options, and second, it impacts an important biomarker that is reasonably likely to predict a clinical benefit to patients.
In the specific case of Leqembi, the data from Phase 2 clinical trials demonstrate that Leqembi is effective in removing clumps of amyloid, one of the sticky proteins found in the brains of people who have Alzheimer’s disease. It’s hypothesized that removing the buildup of amyloid may help slow the progression of the disease, and in fact, the research results do indicate a modest slowing in the pace of cognitive decline.
Alzheimer’s disease impacts millions of American families (including my own) and is a terribly devastating disease. Because this new medication targets and affects the underlying disease process – rather than just treating the symptoms – its approval by the FDA is an exciting milestone in our ongoing work to help advance new medicines and treatments for Alzheimer’s.
We’re excited about this new approval and looking forward to more to come!