Washington — US health officials on Friday approved a drug for Alzheimer’s that is being closely monitored, despite potential safety risks that patients and their doctors must consider carefully.
Rekenbi is the first drug convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s disease by targeting the underlying biology of Alzheimer’s disease. The Food and Drug Administration has approved it for Alzheimer’s patients, especially those with mild or early stage disease.
Japan’s Eisai and US partner Biogen’s Rekembi are a rare success in a field accustomed to the failure of experimental treatments for incurable diseases. Although the drug probably delays cognitive decline by only a few months, some experts say it could still make a meaningful difference to people’s lives.
“This drug is not a cure. It can’t stop people from getting worse, but it can slow the progression of the disease considerably,” said Dr. Joy Snyder, a neurologist at Washington University in St. Louis. This could mean that we could be driving six months to a year longer.”
Snyder emphasized the drug’s downsides, which include the need for twice-monthly injections and possible side effects such as swelling of the brain.
FDA approval came via its accelerated pathway, which allows drugs to be launched based on early results before they are confirmed to benefit patients. The use of shortcut approaches by government agencies is coming under increasing scrutiny from government oversight bodies 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 “plagued with fraud,” including many meetings with undocumented pharmaceutical company staff. I found that it was full.
The scrutiny of a new drug, chemically known as lecanemab, will determine whether and how insurance companies will cover it, so most patients won’t start receiving it for months. It could mean
The drug typically costs about $26,500 for one year of treatment. Eisai said the price reflects the drug’s benefits in terms of improving quality of life and reducing the burden on caregivers. The company pegs its value at more than $37,000 a year, but said it has cut prices to cut costs for patients and insurers. He said the price of the drug would need to be below $20,600 a year to increase
About 6 million people in the United States and many more worldwide have Alzheimer’s disease. Alzheimer’s disease gradually attacks areas of the brain necessary for memory, reasoning, communication, and daily tasks.
FDA approval is based on one interim study of 800 people with early signs of Alzheimer’s who are still able to live independently or with minimal support.
Since then, Eisai has published the results of a larger study of 1,800 patients, which the FDA has reviewed to confirm the drug’s benefits and is on its way to full approval later this year. Open
A large study tracked patient outcomes on an 18-point scale that measures memory, judgment, and other cognitive abilities. Physicians compile assessments from patient interviews and close contacts. After 18 months, patients receiving Leqembi declined more slowly than those receiving dummy injections. The delay was just over five months.
There is little consensus on whether the differences translate into real benefits for patients, such as greater independence.
“Most patients won’t notice a difference,” says Dr. Matthew Schrag, a neurology researcher at Vanderbilt University. “This is actually a very small effect, probably below the threshold for being called clinically important.”
Schrag and several other researchers believe that meaningful improvement requires a difference of at least 1 point out of 18.
Leqembi works by removing a sticky brain protein called amyloid that is one of the hallmarks of Alzheimer’s disease. However, we do not know exactly what causes this disease. Other series of amyloid-targeted drugs have failed, and many researchers now believe that combination therapy will be necessary.
A similar drug, Aduhelm, has been marred by controversy over its effectiveness.
The FDA approved the drug in 2021, contrary to the FDA’s own outside expert advice. Doctors were reluctant to prescribe the drug, and insurance companies limited coverage.
The FDA did not consult the same panel of experts before approving Leqembi.
Although there is “less drama” surrounding new drugs, Schlag said many of the same concerns apply.
“Is this small, measurable benefit worth the hefty price tag and potential side effects patients experience?” he asked. “I have some pretty serious questions.”
In an Eisai study, about 13% of patients had brain swelling and 17% had small cerebral hemorrhages. This is a side effect seen with previous amyloid-targeting drugs. In most cases, these problems do not cause symptoms such as dizziness or visual disturbances.
Several Leqembi users have also died while taking the drug, including two who were taking blood-thinning drugs. Eisai has said the death was not due to drugs. The FDA label warns physicians to be careful when prescribing Leqembi to patients taking blood thinners.
Insurance companies are likely to only cover the drug for people like the ones who participated in the company’s study—those with mild symptoms and documented amyloid buildup. A scan is required. Another type of scan will be needed to regularly monitor brain swelling and bleeding.
A key issue in the drug’s rollout is determination of coverage by Medicare, the federal health care program for 60 million seniors and other Americans. The agency severely limited his coverage of Aduhelm, essentially wiping out its U.S. market and prompting Biogen to abandon its marketing plans for the drug.
Eisai’s management said it has already spent months discussing data on its drug with Medicare officials. No press is expected until the FDA confirms the drug’s benefits, possibly later this year.
Eisai US CEO Ivan Cheung said:
Betsy Groves, 73, of Cambridge, Massachusetts, was diagnosed with Alzheimer’s disease in 2021. A former lecturer at the Harvard School of Education, she found she had trouble remembering her students’ names and answering their questions.
Her initial diagnosis, based on cognitive testing, was later confirmed by a positive test for amyloid.
Groves says he wants to try Leqembi despite the potential side effects and the need for an IV.
“For me, I plan to take the drug as soon as it’s on the market and has my doctor’s approval.
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