A new drug that appears to slow early Alzheimer’s disease is coming to the market.
The Food and Drug Administration on Friday approved lecanemab, which will be marketed as Leqembi, for public use.
The decision comes after data published in The New England Journal of Medicine in November showed that people who took the drug experienced “moderately less decline on measures of cognition and function.”
However, some patients also experienced negative side effects like brain swelling and bleeding — meaning people will need to receive regular brain scans after starting treatment.
It’s also unclear if Medicare will cover Leqembi, which is expected to cost tens of thousands of dollars each year.
Leqembi is the second drug of its kind to receive market approval and is expected to be more commercially successful than its predecessor, Aduhelm. The controversial treatment, also known as aducanamab, received federal approval in 2021, despite limited results that the drug helped patients.
Here’s what to know:
How does it work?
Leqembi decreases the amount of amyloid plaque in the brain. The protein deposits have long been hypothesized to be linked to the progression of Alzheimer’s.
Reduce the plaque, the theory posits, and you’ll slow the effects of the memory disease.
Existing data on Leqembi provides the strongest support for that theory to date. However, the drug, if effective, is not a cure for Alzheimer’s.
“But it can help people retain memories,” said Stefanie Wardlow, a senior program manager at the Florida Alzheimer’s Association. “So they’re able to enjoy more time.”
The 18-month study published in November, which was funded by its manufacturers and involved people aged 50 to 90 with early Alzheimer’s, nevertheless concluded by noting that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”
Who can take Leqembi?
The intravenous medication is intended for people with mild cognitive impairment or dementia due to Alzheimer’s disease.
People with more advanced Alzheimer’s will likely not be eligible for the treatment.
Given the negative side effects experienced by some patients involved in the study, people should consult their doctors when considering whether to seek out Leqembi.
When will it be available?
Leqembi is expected to become available by the end of January, Wardlow said.
People who are interested and eligible should speak to their doctors about how they can access the drug.
The federal government greenlit Leqembi on an accelerated approval pathway, a conditional status granted to drugs aimed at serious conditions where there is an “unmet medical need.” The drug must also have enough evidence to suggest there is a “likely” clinical benefit for patients.
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The provisional approval means Alzheimer’s patients can start taking Leqembi now while the federal agency continues to review additional data about its effectiveness. The Food and Drug Administration will likely decide whether to grant the drug full approval in the fall, Wardlow said.
How much will it cost?
Esai, which manufactures the drug in partnership with biotech giant Biogen, has said the treatment will cost $26,500 annually.
It’s unclear if the drug will be covered by the Centers for Medicare & Medicaid Services.
In an April 2022 decision, the agency indicated that it generally will not pay for Alzheimer’s treatments aimed at attacking amyloid plaque until they receive full approval by the Food and Drug Administration, except in clinical trial settings.
Critics, including organizations like the Florida Alzheimer’s Association, have asked Medicare to reconsider its policy, stating that out-of-pocket costs will make Leqembi inaccessible for many people with early-onset Alzheimer’s.