New Alzheimer’s Drug Receives FDA Approval

Source: NBC News

The Food and Drug Administration of approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness.

The drug, lecanemab, which will be sold under the name Leqembi, is a monoclonal antibody infusion given every two weeks. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease.

The drug was approved in an accelerated pathway, which allows early approval for promising new medications that “fill an unmet medical need.” The agency said its decision was based on a phase 3 clinical trial of 1,795 patients, which found the drug, developed by drugmakers Eisai and Biogen, slowed cognitive decline in people who received it by 27% after 18 months.

Leqembi is not a cure; it slows the progression of the disease by removing clumps of beta-amyloid — long thought by scientists to be one of the main causes of the disease — from the brain.

Safety concerns have been raised about the drug. At least three deaths may be linked to the medication after the patients experienced brain swelling or brain bleeding.

The drug does have defenders. Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky, said Leqembi should be approved. The data supporting Leqembi’s application is “robust,” she said, adding the results of the trial are the best she has “ever seen for an Alzheimer’s drug in my 25 years.”

The Alzheimer’s Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

The organization is urging the Centers for Medicare & Medicaid Services to revise its decision on new Alzheimer’s treatments. Last year, in response to the poor data supporting Aduhelm’s approval, the CMS said it wouldn’t cover Alzheimer’s drugs that target amyloid unless patients are in a clinical trial.

Making the drug more widely available could mean more patients have “many months more of recognizing their spouse, children and grandchildren,” said Maria Carrillo, the chief science officer for the Alzheimer’s Association.

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