The Food and Drug Administration has fully approved the first drug shown to slow Alzheimer’s disease.
The action means that Leqembi, whose generic name is lecanemab, is expected to be covered extensively by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who are in the early stages of the disease will have access to the drug and be able to afford it.
« It’s not something that’s going to stop the disease or reverse it, » he says Dr 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 appeared to slow declines in memory and thinking by about 27 percent after 18 months of treatment. It also dramatically reduced the sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer’s.
“It is very exciting that we are targeting the actual pathology of the disease,” says Vaishnavi.
Just talking about a treatment « is an incredible point for the cause of Alzheimer’s in general, » she says Joanna Pikepresident and CEO of the Alzheimer’s Association.
Leqembi comes from Japanese pharmaceutical company Eisai and its US partner Biogen. The companies said Leqembi will cost about $26,500 a year.
In January, the drug received what is known as expedited approval by the FDA, based on its ability to remove the substance amyloid beta from the brains of people in the early stages of Alzheimer’s. 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 would expand Leqembi’s coverage the same day the drug receives full FDA approval. That should mean the drug will now be covered for most Medicare patients with early signs of cognitive problems and elevated amyloid levels.
Wider coverage, limited use
Until now, Medicare has only paid for Leqembi for patients in a few clinical trials.
Under the 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 in the next year or so.
One reason is the drug’s potentially life-threatening side effects, says Vaishnavi.
« I think [patients] they are a bit wary because they hear about bleeding or swelling in the brain, » says Vaishnavi. « They are concerned, and I think rightly so. »
Another limiting factor is that the US health care system is simply not prepared to diagnose, treat and monitor large numbers of Alzheimer’s patients, Pike says.
Leqembi requires an initial test to determine amyloid levels in the brain, intravenous infusions every other week, and periodic brain scans to detect side effects.
« We don’t have enough specialists who understand how to deliver this treatment, » says Pike. « We don’t have enough primary care physicians with the knowledge and confidence to provide a referral. »
But Leqembi has far more support from doctors and payers than an unfortunate predecessor.
In 2021, the FDA granted conditional approval to a drug called Aduhelm. It also removes amyloid from the brain.
But it wasn’t clear whether Aduhelm, also known as aducanumab, slowed the loss of memory 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 these problems.
« You really have nothing to lose »
« It appears that the scientific and clinical community understands the difference right now between Leqembi and Aduhelm, » says Pike.
Much of what scientists have learned about Leqembi is thanks to people like Ken and Susan Bell in St. Charles, Missouri.
Susan, who is 70, started showing signs of Alzheimer’s about four years ago. She then enrolled in a clinical trial of Leqembi at Washington University in St. Louis and has been receiving the drug ever since.
The drug didn’t stop the disease, though.
« There was, certainly, some degradation in his cognitive powers and so forth, » says Ken.
But Susan’s decline has been relatively slow. The couple is still able to travel and play golf, which could indicate the drug is working.
« We don’t have enough experience, as doctors do, to know what would have happened » without the drug, Ken says.
However, Susan thinks other people in the early stages of Alzheimer’s should try Leqembi.
« I’d tell them, ‘Go for it,' » she says, « because you really have nothing to lose. »