Breakthrough Alzheimer’s drug earns accelerated FDA approval

A new, breakthrough drug designed to aggressively treat Alzheimer’s disease was awarded accelerated approval by the Food and Drug Administration on Friday.

Leqembi — developed by Tokyo-headquartered Eisai — has been shown in trials to slow the cognitive and functional decline of people in the early stages of the illness. The accelerated approval comes amid concerns about the safety and the cost of the drug, previously known as lecanemab.

Massachusetts-based Biogen and Eisai will market the medication, which is a monoclonal antibody infusion every two weeks. It’s approved for use in patients with mild cognitive impairment or in the mild dementia stage of the disease.

“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,” Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The approval of Leqembi was streamlined following the results of a study of 856 Alzheimer’s patients given a dose every two weeks, the FDA stated.

“These results support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease,” the agency announced.

The agency said it “soon” expects to review data from an 18-month study that showed the drug slowed cognitive and memory decline by around 27%.

Using the Accelerated Approval pathway, the FDA may approve drugs for serious conditions where there is an unmet medical need and drugs shown to have an effect that is “reasonably” likely to predict a clinical benefit to patients. 

Leqembi is expected to cost around $25,000 annually per patient, Ivan Cheung, the US chairman and CEO of Eisai, told NBC News. 

The outlet noted at least three deaths may be linked to the drug, with the patients reportedly experiencing brain swelling or brain bleeding.

Eisai, meanwhile, was quick to acknowledge what a game-changer the medication may be. Alzheimer’s disease is the seventh-leading cause of death in the US, according to the Centers for Disease Control and Prevention.

“Leqembi has the potential to make a difference for people living with early Alzheimer’s disease (AD), their loved ones and healthcare professionals,” global safety officer Stewart Geary announced.

“We are incredibly grateful to patients, families and the healthcare provider community for their participation in clinical research to help combat AD and all other devastating diseases.”