7/7/23 - The FDA Fully Approves The First Drug Shown To Slow Alzheimer's Disease

Alzheimer's Disease drug Leqembi, should be widely covered by the federal Medicare health insurance program.

- The U.S. Food and Drug Administration on Thursday granted traditional approval for the Alzheimer's drug lecanemab, known by the brand name Leqembi. 

This is considered to be the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit for the disease.

Leqembi, is from drugmakers Eisai and Biogen, and has shown to slow the progression of Alzheimer's disease, including declines in memory and thinking. 

The goal is to make the drug accessible to eligible patients as soon as possible. 

According to the latest news release, the decision was unanimous, with all committee members voting that the study results verified the drug's benefit and that it is a safe and effective treatment for patients with Alzheimer's disease.  The drug is not a cure and doesn't stop people from getting worse, but it down slow the progression of the disease. 

Leqembi also comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling. Other reported side effects are infusion-related reactions and headaches, according to the Alzheimer's Association.  Access is another issue, with the drug expected to be priced at about $26,500 for a typical year's worth of treatment, without insurance. 

More information: U.S. Food and Drug Administration (fda.gov)