US approves Alzheimer’s drug that moderately slows disease

US approves Alzheimer’s drug that moderately slows disease

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WASHINGTON — U.S. health officials on Friday approved a closely-watched Alzheimer’s drug that slightly slows the brain-sapping disease, albeit with potential safety risks that patients and their doctors must carefully weigh.

The drug Leqembi is the first that has been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s disease by targeting the disease’s underlying biology. The Food and Drug Administration has approved it for patients with Alzheimer’s, particularly those with mild or early-stage disease.

Leqembi, by Japanese company Eisai and its US partner Biogen, is a rare success in a field accustomed to failed experimental treatments for the incurable disease. The delay in cognitive decline caused by the drug is likely only a few months, but some experts say it could still significantly improve people’s lives.

“This drug is not a cure. It doesn’t stop people from getting worse, but it measurably slows the progression of the disease,” said Dr. Joy Snider, a neurologist at Washington University in St. Louis. “That could mean someone can drive six months to a year longer.”

Snider stressed that the drug, pronounced “leh-KEM-bee,” has downsides, including requiring twice-monthly IVs and potential side effects like brain swelling.

The FDA approval came through their accelerated pathway, which allows drugs to be brought to market based on early results before they are confirmed to benefit patients. The agency’s use of this shortcut approach has come under increasing 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 “riddled with irregularities,” including a series of meetings with drug company employees that went undocumented.

Scrutiny of the new drug, known chemically as lecanemab, will likely mean most patients won’t receive it for months as insurers decide if and how to cover it.

The drug costs about $26,500 for a typical treatment period of one year. 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 valued it at over $37,000 a year, but said it lowered the price to reduce costs for patients and insurers. An independent group that assesses the drug’s value recently said that the drug would need to price under $20,600 per year to be cost-effective.

About 6 million people in the United States and many more worldwide have Alzheimer’s disease, which progressively attacks areas of the brain needed for memory, reasoning, communication and daily tasks.

The FDA’s approval was based on a mid-stage study of 800 people with early signs of Alzheimer’s who were still able to live independently or with minimal support.

Eisai has since released the results of a larger study of 1,800 patients that the FDA will review to confirm the drug’s benefits and pave the way for full approval later this year.

The larger study tracked patients’ scores on an 18-point scale that measures memory, judgment and other cognitive skills. Doctors create the assessment from interviews with the patient and close contact. After 18 months, the patients receiving Leqembi lost weight more slowly – a difference of less than half a point on the scale – than those receiving a sham infusion. The delay was just over five months.

There is little consensus as to whether this difference translates into real benefits for patients, such as greater independence.

“Most patients won’t notice the difference,” said Dr. Matthew Schrag, neurology researcher at Vanderbilt University. “It’s really quite a small effect and probably below the threshold of what we would call clinically significant.”

Schrag and some other researchers believe that a meaningful improvement would require at least a full point difference on the 18-point scale.

Leqembi works by clearing a sticky brain protein called amyloid, which is a hallmark of Alzheimer’s. But it’s not clear what exactly causes the disease. A number of other amyloid drugs have failed, and many researchers now believe combination treatments will be needed.

Aduhelm, the similar drug, has been marred by controversy over its effectiveness.

The FDA approved this drug in 2021 against the advice of the agency’s own outside experts. Doctors were reluctant to prescribe the drug and health insurance companies reduced coverage.

The FDA did not consult the same panel of experts before approving Leqembi.

While there’s “less drama” surrounding the new drug, Schrag said many of the same concerns apply.

“Is this small, measurable benefit worth the high price and side effects patients may experience?” he asked. “I have pretty serious doubts.”

About 13% of patients in Eisai’s study had brain swelling and 17% had mild cerebral hemorrhage, side effects seen with previous amyloid-targeted drugs. In most cases, these problems didn’t cause any symptoms, which can include dizziness and blurred vision.

Also, several Leqembi users died while taking the drug, including two who were taking blood-thinning medication. Eisai has said the deaths cannot be attributed to the drug. The FDA label warns doctors to exercise caution when prescribing Leqembi to patients taking blood thinners.

Insurers will likely only cover the drug for people like those in the company’s study – patients with mild symptoms and confirmed amyloid formation. That usually requires expensive brain scans. A separate type of scan is needed to periodically monitor the brain for swelling and bleeding.

A key issue in getting the drug to market will be the coverage decision of Medicare, the federal health plan that covers 60 million seniors and other Americans. The agency severely restricted coverage of Aduhelm, essentially wiping out its US market and causing Biogen to abandon marketing plans for the drug.

Eisai executives said they had already spent months discussing dates of their medications with Medicare officials. Coverage is not expected until after the FDA confirms the drug’s benefits, likely later this year.

“Once we have a Medicare decision, we can really roll out the drug across the country,” said Ivan Cheung, Eisai’s US CEO.

Betsy Groves, 73, of Cambridge, Massachusetts, was diagnosed with Alzheimer’s in 2021. As a former faculty member at Harvard School of Education, she found she had trouble remembering some student names and answering questions.

Her initial diagnosis, based on a cognitive exam, was later confirmed by a positive test for amyloid.

Groves says she’s “more than willing” to try Leqembi, despite potential side effects and the need for IVs.

“For me, once the drug hits the market — and I get my doctor’s approval — I’m going to take it,” Groves said.

Copyright © 2023 by The Associated Press. All rights reserved.

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