U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain disease. The FDA granted accelerated approval Friday for patients in early stages of Alzheimer’s.
David Duprey/AP
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David Duprey/AP
U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain disease. The FDA granted accelerated approval Friday for patients in early stages of Alzheimer’s.
David Duprey/AP
The Food and Drug Administration has approved a drug that may help people in the early stages of Alzheimer’s maintain their mental abilities.
Lecanemab, which will be marketed as Leqembi, is likely to reach many more patients than a similar product, Aduhelm, which flopped after receiving a controversial approval in 2021.
“This is a milestone for people eligible for this treatment, for their families, for the research community,” says Maria Carrillo, chief science officer for the Alzheimer’s Association.
But Leqembi, like Aduhelm, can cause swelling or bleeding in the brain, which means patients must receive periodic brain scans after starting treatment. It’s also unclear whether Medicare and private health insurers will cover the drug, which is likely to cost tens of thousands of dollars each year.
Eisai and Biogen, the companies that developed Leqembi, have not yet announced pricing.
The new drug, which is given intravenously every other week, removes a substance called amyloid from the brain. Sticky amyloid plaques are a hallmark of Alzheimer’s, though many previous drugs that targeted amyloid failed to slow down patients’ loss of mental abilities.
In a study of 1800 people with early Alzheimer’s, those who got Leqembi for 18 months experienced 27 percent less decline in memory and thinking.
That’s a modest benefit, says Dr. Joy Snider, a professor of neurology at Washington University School of Medicine in St. Louis.
“It’s not a cure. It doesn’t stop the disease completely. It doesn’t make people get better,” Snider says. “But it does slow down progression in very mild disease.”
And even a modest slowing could be meaningful to patients and their families, says Snider, who helped conduct the study that found a benefit.
“Maybe you could keep driving for an extra six months or a year,” she says. “Maybe you could keep doing your checkbook for an extra six months to a year.”
It could be many months, though, before Leqembi reaches many of the millions of patients who might benefit.
To qualify for treatment, people need to undergo tests showing that they are in the early stages of dementia and that their brains contain the amyloid deposits that are a hallmark of Alzheimer’s. That process is likely to include at least two visits to specialists, who are in short supply.
The result is likely to be a very long queue, says Jakub Hlávka, a health policy expert at the University of Southern California.
“Roughly speaking we can expect that to take about five years before all the currently eligible patients may get cleared through that queue,” he says.
Leqembi received what’s known as accelerated approval, a conditional okay to market a drug, based on its ability to remove amyloid from the brain. The FDA is likely to consider a full approval later this year, after reviewing the evidence that the drug also helps preserve mental function.
Carrillo is confident the drug will receive full approval.
“The science speaks for itself,” she says. “The science is telling us that lowering amyloid is leading to clinical benefit.”
But until Leqembi has full FDA approval, Medicare is unlikely to cover it.
