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:
On November 15, 2024, the Centers for Medicare and Medicaid Services posted the 2025 spousal…
The word disability doesn't have the same meaning in all contexts. If you have a…
On October 10, 2024, the Social Security Administration announced that Americans will increase a 2.5…
Many people think that estate planning is just having documents prepared. They have a lawyer…
In Chambers v. Edwards, 365 Ga. App. 482 (2022), William Chambers sued his sister, Kathy…
When an injured party sues someone who negligently injured him or her, one form of…