The Food and Drug Administration has fully approved Leqembi, the first drug proven to slow Alzheimer’s disease.
Andrew Harnik/AP
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Andrew Harnik/AP
The Food and Drug Administration has fully approved Leqembi, the first drug proven to slow Alzheimer’s disease.
Andrew Harnik/AP
The Food and Drug Administration has fully approved the first drug proven to slow Alzheimer’s disease.
This action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal health insurance program Medicare, which primarily serves adults 65 years of age and older. So more people in the early stages of the disease will have access to the drug – and be able to afford it.
“It’s not something that will prevent or reverse disease,” says doctor . Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center. “But it can slow the progression of the disease and can give people more meaningful time with their families.”
In studies reviewed by the FDA, Leqembi seemed to slow the decline of memory and thinking by about 27% after 18 months of treatment. It also significantly reduced sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer’s disease.
“It’s exciting that we’re targeting the real pathology of this disease,” Vaishnavi said.
Just talking about a treatment “is a staggering point for the etiology of Alzheimer’s disease in general,” says Joanne PikePresident and CEO of the Alzheimer’s Association.
Leqembi comes from Japanese pharmaceutical company Eisai and US partner Biogen. The companies say Leqembi will cost about $26,500 a year.
In January, the drug received the so-called fast approval from the FDA, based on its ability to clear beta-amyloid from the brains of people in the early stages of Alzheimer’s disease. The full or traditional approval reflects the FDA’s assessment that Leqembi also helps preserve memory and thinking.
Also in January, the Centers for Medicare and Medicaid Services announced it will expand Leqembi’s coverage on the same day the drug receives full FDA approval. That means the drug will now be covered for most Medicare patients with early signs of cognitive problems and elevated amyloid levels.
Wider coverage, limited use
So far, Medicare has only paid Leqembi to patients in certain clinical trials.
Under expanded coverage, one million or more Medicare patients are potential candidates for the drug. But it’s likely that a much smaller number will actually get it next year or so.
Vaishnavi said one reason is the potentially life-threatening side effects of the drug.
“I think [patients] “They are worried and I think so,” Vaishnavi said.
Another limiting factor is that the US health care system is simply not prepared to diagnose, treat and monitor a large number of Alzheimer’s patients, Pike said.
Leqembi requires initial testing to determine amyloid levels in the brain, a biweekly intravenous infusion, and periodic brain scans to detect side effects.
“We don’t have enough experts to understand how to deliver this treatment,” says Pike. “We don’t have enough primary care physicians with the knowledge and confidence to recommend.”
But Leqembi actually gets more support from doctors and payers than its ill-fated predecessor.
In 2021, the FDA granted a conditional authorization for a drug called Aduhelm. It also removes amyloid from the brain.
But it’s not clear if Aduhelm, also known as aducanumab, slows memory loss and thinking. So many doctors refused to prescribe it. And Medicare has refused to cover the expensive drug, except for patients in some clinical trials.
Leqembi shouldn’t have those problems.
‘You really have nothing to lose’
“It seems that the scientific community and clinicians understand the difference at this point between Leqembi versus Aduhelm,” says Pike.
Much of what scientists know about Leqembi comes from the likes of Ken and Susan Bell of St. Charles, Missouri.
Susan, 70, started showing signs of Alzheimer’s about four years ago. So she enrolled in a clinical trial of Leqembi at Washington University in St. Louis and have been receiving the drug ever since.
However, the drug did not stop the disease.
Ken said: “There must have been some deterioration in her cognitive abilities, etc.
But Susan’s decline was relatively slow. The couple can still travel and play golf, which could signal that the medication is working.
“We don’t have enough experience, like medical professionals, to know what would happen” without the drug, says Ken.
However, Susan thinks that others in the early stages of Alzheimer’s should try Leqembi.
“I would tell them, ‘Just do it,'” she said, “because you really have nothing to lose.”
