FDA grants fast-track approval for Alzheimer’s drug Leqembi: Shots
US health authorities have approved a new Alzheimer’s drug, Leqembi, that slightly slows brain disease. On Friday, the FDA granted accelerated approval for patients with early-stage Alzheimer’s disease.
David Duprey/AP
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David Duprey/AP

US health authorities have approved a new Alzheimer’s drug, Leqembi, that slightly slows brain disease. On Friday, the FDA granted accelerated approval for patients with early-stage Alzheimer’s disease.
David Duprey/AP
The Food and Drug Administration has approved a drug to help people with early stages of Alzheimer’s disease maintain their mental abilities.
Lecanemab, marketed as Leqembi, is expected to reach far more patients in 2021 than the similar product Aduhelm, which failed after a controversial approval.
“This is an important step for people who are eligible for this treatment, their families, and the research community,” said Maria Carrillo, director of research at the Alzheimer’s Association.

But Leqembi, like Aduhelm, can cause swelling or bleeding in the brain, which means patients should have periodic brain scans after starting treatment. It’s also unclear whether Medicare and private health insurers will cover the drug, which costs tens of thousands of dollars each year.
Eisai, the company that developed Leqembi in partnership with another drugmaker, Biogen, said the treatment costs $26,500 a year.
A new drug, given intravenously every two weeks, removes a substance called amyloid from the brain. Sticky amyloid plaques are a hallmark of Alzheimer’s disease, but many previous drugs that target amyloid have failed to slow patients’ cognitive decline.
In a study of 1,800 people with Alzheimer’s disease, those who took Leqembi for 18 months had a 27% decline in memory and thinking ability.

It’s a modest benefit, says Dr. Joy Snyder, a professor of neurology at Washington University School of Medicine in St. Louis.
“This is not a cure. It cannot completely stop the disease. It doesn’t make people better,” Snyder says. “But it slows the progression of very mild disease.”
Even modest slowdowns can be significant for patients and their families, says Snyder, who helped lead the study that found the benefits.
“Maybe you can drive another six months or a year,” he says. “Maybe you can build your checkbook for another six months to a year.”
However, it may be months before Leqembi reaches most of the millions of patients who could benefit.

To be eligible for the treatment, people must pass tests that show they have early stages of dementia and that they have amyloid deposits in their brains, a hallmark of Alzheimer’s disease. This process may involve at least two visits to specialists, of which there are not enough.
According to Jakub Hlawka, a health policy expert at the University of Southern California, the results could be a long way off.
“Basically, we can expect it to take about five years for currently eligible patients to get through that queue,” he says.
Leqembi received what’s called an accelerated approval, a conditional agreement to market the drug based on its ability to remove amyloid from the brain. The FDA may consider full approval later this year after reviewing evidence that the drug helps maintain mental function.
Carrillo is confident that the drug will receive full approval.
“The science speaks for itself,” he says. “Science tells us that reducing amyloid has clinical benefits.”
But until Leqembi is fully FDA approved, Medicare is unlikely to cover it for most patients. The cause is related to the old Alzheimer’s drug Adukhelm.
After Aduhelm received fast-track approval in 2021, the Centers for Medicare and Medicaid Services decided that Medicare would cover the drug only for patients enrolled in certain clinical trials. The agency said it did not want to recommend broader coverage for an Alzheimer’s drug that has not been clearly shown to preserve memory and thinking.
The ruling applies not only to Aduhelm, but to all Alzheimer’s drugs targeting amyloid that have not received full FDA approval.
So for now, most patients who want Leqembi will have to pay out of pocket.
“Without coverage, we’re talking about a breakthrough that’s not available to American society,” Carrillo said. “And that’s unacceptable.”
If Medicare and other payers start covering Leqembi, the cost could climb to tens of billions of dollars a year, Hlavka said. The cost is so high, he said, that payers and federal officials may want to consider a new way to care for people with dementia.
“One potential solution is to put all dementia patients covered by different plans into one risk pool and then see if we can provide coordinated access and care to those patients,” Hlawka said.
This would allow the government to offset the cost of the drug against the potential savings if people with dementia are able to defer expensive nursing home care, he says. It will also make it easier for the government to negotiate Lekembi’s price.
There is a precedent for putting all those suffering from this disease under one umbrella, says Hlavka.
Since the early 1970s, Medicare has had a special program for people of all ages with kidney failure. The program now costs Medicare about $9 billion a year.
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