Rare Success Against Alzheimer's: FDA Approves a Fast-Tracked Treatment
U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, albeit with potential safety risks that patients and their doctors will have to weigh carefully.
The drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease’s underlying biology.
The Food and Drug Administration approved the drug for patients with Alzheimer’s, specifically those with mild or early stage disease.
Leqembi, from Japan’s Eisai and its U.S. partner Biogen, is a rare success in a field accustomed to failed experimental treatments for the incurable condition. The delay in cognitive decline brought about by the drug likely amounts to just several months, but Dr. Joy Snider and some other experts say it could still meaningfully improve people’s lives.
“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” said Snider, a neurologist at Washington University in St. Louis. “That might mean someone could have an extra six months to a year of being able to drive.”
Snider stressed that the medicine, pronounced “leh-KEM-bee,” comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling.
The FDA approval came via its accelerated pathway, which allows drugs to launch based on early results, before they’re confirmed to benefit patients. The agency’s use of that shortcut approach has come under increased scrutiny from government watchdogs and congressional investigators.
Last week, a congressional report found that the FDA’s approval of a similar Alzheimer’s drug, called Aduhelm — also from Biogen and Eisai — was “rife with irregularities,” including several meetings with drug company staffers that went undocumented.
Scrutiny of Leqembi, known chemically as lecanemab, likely will mean most patients won’t start receiving it for months, as insurers decide whether and how to cover it.
Some 6 million people in the United States and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.
The FDA’s approval was based on one mid-stage study in 800 people with early signs of Alzheimer’s who still were able to live independently or with minimal assistance.
Several Leqembi users died while taking the drug, including two who were on blood-thinning medications. Eisai has said the deaths can’t be attributed to the drug. The FDA label warns doctors to use caution if they prescribe Leqembi to patients on blood thinners.
Since the mid-stage study was done, Eisai has published the results of a larger 1,800-patient study that the FDA will review to confirm the drug’s benefit, paving the way for full approval later this year.
Dr. Matthew Schrag, a neurology researcher at Vanderbilt University, expressed caution about the new drug.
“Most patients won’t notice the difference,” he said. “This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”
Leqembi works by clearing a sticky brain protein called amyloid that’s one hallmark of Alzheimer’s. But it’s not clear exactly what causes the disease.
A string of other amyloid-targeting drugs have failed, and many researchers now think combination treatments will be needed.
Betsy Groves, 73, of Cambridge, Mass., was diagnosed with Alzheimer’s in 2021. A former lecturer at Harvard’s school of education, she noticed she was having trouble remembering some student names and answering questions.
Her initial diagnosis, based on a cognitive examination, was later confirmed by a positive test for amyloid.
Groves said she is “more than willing” to try Leqembi, despite potential side effects and the need for infusions.
“For me, the minute that drug comes on the market — and I get my doctor’s approval — I’m going to take it,” Groves said.
The Western Journal has reviewed this Associated Press story and may have altered it prior to publication to ensure that it meets our editorial standards.
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