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Alzheimer’s Disease Treatment Granted Accelerated Approval

January 7, 2023 • 1:04 pm CST
by Kim Heimbuch
(Precision Vaccinations)

The U.S. Food and Drug Administration (FDA) recently approved Eisai R&D Management Co., Ltd.'s Leqembi for treating Alzheimer's disease.

Leqembi (lecanemab-irmb) is the second of a new category of medications approved for Alzheimer's disease that target the fundamental pathophysiology of the disease.

In July 2021, the FDA approved Aduhelm, an amyloid beta-directed antibody indicated to treat Alzheimer’s disease. 

These medications represent an essential advancement in the ongoing fight to effectively treat Alzheimer's disease.

The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.

The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

The FDA granted this application Fast Track, Priority Review, and Breakthrough Therapy designations.

"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, in a press release on January 6, 2023.

"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 results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported, and the agency anticipates receiving the data soon.

Alzheimer's disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that 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 the loss of neurons and their connections.

These changes affect a person's ability to remember and think.

As of January 7, 2023, the FDA has not approved an Alzheimer's disease vaccine. However, there are several conducting clinical trials.

Disclosure: FDA and NIH announcements were manually curated.