Not a Cure: New Alzheimer’s Drug Given Green Light 

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An experimental Alzheimer’s drug that moderately slows cognitive decline was approved by the Food and Drug Administration (FDA) on Friday.

The drug, called lecanemab, was granted conditional approval based on a study finding it reduced levels of a protein called amyloid from the brains of people with early-stage Alzheimer’s.

• FDA’s decision comes after the agency faced enormous criticism and a congressional investigation for its approval of Aduhelm, a similar type of Alzheimer’s drug.
• There were serious concerns about Aduhelm’s efficacy, and even though lecanemab has received a warmer reception from experts, the Aduhelm controversy will likely reverberate.

Lecanemab was approved through the agency’s accelerated pathway, which the FDA can use to approve drugs based on early trial results for serious conditions where there is an unmet medical need, and if the drug is shown to have a reasonable clinical benefit to patients.

“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,” Billy Dunn, director of the FDA’s Office of Neuroscience, said in a statement.

The medication will be sold under the brand name Leqembi and marketed by Japan’s Eisai and its U.S. partner Biogen, which also manufactured Aduhelm.

Cost: Leqembi is given as an infusion twice a month. In a statement, Eisai said the drug will cost an average of $26,500 per year per patient.

• Since Alzheimer’s disease primarily impacts seniors who are eligible for Medicare, taxpayers will largely foot the bill for the new drug if it is covered. Roughly 6 million people suffer from the disease in the U.S.
• The Centers for Medicare & Medicaid Services last spring said it will only cover anti-amyloid drugs that were granted accelerated approval if patients are enrolled in a clinical trial. There are no ongoing trials for Leqembi.