USA — The U.S. Food and Drug Administration (FDA) 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 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, the company that developed Leqembi in partnership with fellow drugmaker Biogen, has said it will price the treatment at US$26,500 per year.
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.
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.
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.
But until Leqembi has full FDA approval, Medicare is unlikely to cover it for many patients. The reason has to do with the earlier Alzheimer’s drug, Aduhelm.
After Aduhelm received accelerated approval in 2021, the Centers for Medicare and Medicaid Services ruled that Medicare would cover the drug only for patients enrolled in certain clinical trials.
The agency said it was unwilling to offer wider coverage for an Alzheimer’s drug that had not clearly shown it could preserve memory and thinking.
The ruling applies not just to Aduhelm, but to all Alzheimer’s drugs that target amyloid and have not received full FDA approval. So, for now, most patients who want Leqembi will have to pay for it out of pocket.
Alzheimer’s disease affects an estimated 5 million Americans. According to the Centers for Disease Control, the number of people with Alzheimer’s disease doubles every five years after the age of 65, with the total number of Americans with the disease expected to nearly triple to 14 million by 2060.