Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. The disease slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. These changes affect a person’s ability to remember and think.
Recently, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway 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. It also dramatically reduced the sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer’s.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
The Alzheimer’s drug Leqembi will soon be widely accessible. Leqembi comes from the Japanese pharmaceutical company Eisai and its U.S. partner Biogen. The companies have said Leqembi will cost about $26,500 a year. Medicare said it would cover much of its high cost.