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FDA approves new Alzheimer’s drug that moderately slows disease

AP Photo/David Duprey
FILE – This Oct. 7, 2003 file photo shows a closeup of a human brain affected by Alzheimer’s disease, on display at the Museum of Neuroanatomy at the University at Buffalo in Buffalo, N.Y. On Friday, Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease. The Food and Drug Administration granted the approval Friday for patients in the early stages of Alzheimer’s. (AP Photo/David Duprey)

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. 

The drug was approved through the agency’s accelerated pathway, which 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.

The companies announced in September that the drug slowed cognitive decline by 27 percent compared to a placebo. While modest, the results were the first to show that reducing amyloid can benefit patients. 

The approval gives Biogen another shot at the Alzheimer’s drug market after the disastrous rollout of its previous drug Aduhelm amid cost and efficacy concerns.

Last week, a congressional investigation found FDA’s 2021 approval of Aduhelm was “rife with irregularities.” Aduhelm was granted fast track approval despite serious concerns about its effectiveness, and against the advice of FDA’s own outside advisory panel. 

The agency did not seek an advisory panel opinion with Leqembi.

Both Aduhelm and Leqembi target clumps of amyloid plaque that build up in the brain. Reducing that plaque is thought to slow the progression of Alzheimer’s, but it is not a cure. 

Anti-amyloid drugs also have been shown to produce serious side effects, and Eisai and Biogen said patients in the trial experienced brain swelling and bleeding.

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

As part of its review of Aduhelm, the Centers for Medicare & Medicaid Services (CMS) 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.

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.

CMS won’t make a reimbursement decision until later this year, but in a statement the agency said it is examining the available information and “may reconsider its current coverage based on this review.”

The Alzheimer’s Association is calling on CMS to reverse its decision, and submitted a formal request asking the agency to remove the requirement that Medicare beneficiaries be enrolled in a research study in order to receive coverage.

“The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug’s evidence. CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer’s,” Joanne Pike, Alzheimer’s Association president and CEO said in a statement.

“Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months — memories, skills and independence. They’re losing time.”

Updated at 4:32 p.m.

Tags alzheimer's disease drug approval drug pricing fda

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