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WASHINGTON, Jan. 7 (AP) — U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, although patients and their doctors Potential security risks must be carefully weighed.
The drug, called Leqembi, is the first to be shown to slow memory and thinking decline by targeting the underlying biology of Alzheimer’s disease. The FDA approves it for use in Alzheimer’s patients, particularly those with mild or early-stage disease.
Leqembi, from Japan’s Eisai and its U.S. partner Biogen, has achieved rare success in a field accustomed to failing experimental treatments for incurable diseases. The delay in cognitive decline from the drug may be only a few months, but some experts say it can still significantly improve people’s lives.
“This drug isn’t a cure. It doesn’t stop people from getting worse, but it does significantly slow the progression of the disease,” says Dr. Joy Snider, a neurologist at Washington University in St. Louis. “It could mean an extra six months to a year for someone to drive.”
Snider emphasized that the drug, pronounced “leh-KEM-bee,” has drawbacks, including the need for twice-monthly infusions and the potential for side effects such as brain swelling.
The FDA’s approval came through its accelerated pathway, which allows drugs to be launched based on early results before they are confirmed to be beneficial to patients. The agency’s use of such shortcuts has come under increasing scrutiny from government regulators 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 “ridden with violations,” Multiple meetings, including with employees of pharmaceutical companies, were not recorded.
The review of the new drug, chemically known as lecanemab, could mean most patients won’t start receiving it for months as insurers decide whether and how to cover it.
The drug usually costs about $26,500 for a year of treatment. Eisai said the price reflects the drug’s benefits in terms of improved quality of life, reduced burden on caregivers and other factors. The company pegs its value at just over $37,000 a year, but says its lower pricing is meant to keep costs down for patients and insurers. An independent group assessing the drug’s value recently said the drug must be priced below $20,600 a year to be cost-effective.
About 6 million people in the United States, and many more worldwide, suffer from Alzheimer’s disease, which progressively attacks the areas of the brain responsible for memory, reasoning, communication, and daily work.
The FDA approval was based on an interim study of 800 people with early signs of Alzheimer’s who were still able to live independently or with minimal assistance.
Since then, Eisai has released results from 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.
A larger study tracked patient outcomes on an 18-point scale measuring memory, judgment and other cognitive abilities. Physicians compile the ratings based on interviews with patients and close contacts. After 18 months, those who received Leqembi declined more slowly than those who received the mock infusion — a proportional difference of less than half a point. The delays add up to just over five months.
There is little consensus on whether this difference confers real benefits for patients, such as greater independence.
“Most patients won’t notice a difference,” said Dr. Matthew Schrag, a neurology researcher at Vanderbilt University. “It’s really a small effect, probably below the threshold we call clinical significance.”
Schrager and some other researchers argue that meaningful improvement requires at least one perfect score on the 18-point scale.
Leqembi works by clearing a sticky brain protein called amyloid, which is a hallmark of Alzheimer’s disease. But it’s not clear what exactly causes the disease. A series of other amyloid-targeting drugs have failed, and many researchers now believe that combination treatments are needed.
A similar drug, Aduhelm, has been controversial for its effectiveness.
The FDA approved the drug in 2021 against the advice of experts outside the agency. Doctors are hesitant to prescribe and insurance companies limit coverage.
The FDA did not consult the same panel of experts before approving Leqembi.
While there is “less drama” surrounding the new drug, Schrag said many of the same concerns apply.
“Is this small, measurable benefit worth the high cost and the side effects patients may experience?” he asked. “I have very serious doubts.”
In Eisai’s study, about 13 percent of patients had brain swelling and 17 percent had small brain hemorrhages, side effects of earlier amyloid-targeting drugs. In most cases, these problems cause no symptoms, including dizziness and vision problems.
In addition, several Leqembi users died while taking the drug, two of whom were taking the blood-thinning drug. Eisai said the deaths could not be attributed to the drug. The FDA label warns doctors to be careful if they prescribe Leqembi to patients on blood thinners.
Insurance companies may only cover the drug for those in the company’s studies — patients with milder symptoms and confirmed amyloid buildup. This often requires expensive brain scans. A separate type of scan is needed to regularly monitor for brain swelling and bleeding.
A key issue in the drug’s rollout will be coverage decisions for Medicare, the federal health program that covers 60 million seniors and other Americans. The agency severely limited Aduhelm’s coverage, essentially eliminating its U.S. market and prompting Biogen to abandon plans to market the drug.
Eisai executives said they had spent months discussing their drug data with health insurance officials. Coverage isn’t expected until the FDA confirms the drug’s benefits, possibly later this year.
“Once we make the Medicare decision, we can really launch the drug nationwide,” said Ivan Cheung, Eisai’s U.S. chief executive.
Betsy Groves, 73, of Cambridge, Mass., was diagnosed with Alzheimer’s in 2021. As a former lecturer at the Harvard School of Education, she found herself having trouble remembering some of her students’ names and answering questions.
Her initial diagnosis was based on cognitive testing, which was later confirmed by a positive amyloid test.
Groves said she was “very willing” to try Leqembi, despite the potential side effects and need for infusions.
“For me, the moment a drug hits the market — I get my doctor’s approval — I take it,” Groves said. (Associated Press)
(This is an unedited and auto-generated story from a Syndicated News feed, the content body may not have been modified or edited by LatestLY staff)
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