December 9, 2023

The first Alzheimer’s disease drug shown in trials to slow disease progression has won full approval from the U.S. Food and Drug Administration (FDA), paving the way for its expensive price tag to be covered by Medicare.

In January, Japan’s Eisai Pharmaceutical Co.’s Leqembi received accelerated FDA approval for drugs with unmet medical needs, but is expected to cost about $26,500 a year.

Leqembi, the trade name for Lecanemab, is an intravenous drug that works to reduce the sticky amyloid plaques that form in the brain as Alzheimer’s disease progresses. In trials, it has shown dramatic results, slowing the rate of decline in memory and thinking skills by up to 27% in people with milder early symptoms of the disease.

Leqembi, an antibody administered intravenously twice a month, will benefit many of the more than 6 million U.S. adults living with Alzheimer’s disease.

“This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to be independent,” said Joanne Pike, president and CEO of the Alzheimer’s Association. And do what you love.” “It gives people more time to recognize their spouses, children, and grandchildren. It also means more time for a person to drive safely, accurately, and on time, take care of family finances, and Get fully involved with hobbies and interests.”

But the drug can have some very serious side effects. In the clinical trial called Study 301, about 13 percent of the 1,795 participants experienced brain swelling or bleeding. Leqembi requires monitoring with brain scans and is at greater risk for people who are also taking blood-thinning medications or who have a genetic predisposition to Alzheimer’s disease (homozygous for the ApoE ε4 allele).

However, the most common side effects were headache and infusion-related reactions. Amyloid-related imaging abnormalities (ARIA) also occur, most commonly as temporary swelling of an area of ​​the brain that usually resolves in time.

“Today’s action is the first to validate that a drug that targets the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. Confirmatory studies confirm that it is a safe and effective treatment for Alzheimer’s patients.”

source: US Food and Drug Administration