The Food and Drug Administration just approved lecanemab from Eisai Co. and partner Biogen Inc. based on an early study finding it reduced a sticky plaque, or amyloid, in the brains of people with early-stage Alzheimer’s. The companies will sell it under the brand name Leqembi.
The drug is only the second approved by the agency, after Biogen’s Aduhelm, for the treatment of brain amyloid.
Here’s what you need to know about Leqembi, and whether you would be able to get it and pay for it:
What is the newly approved drug?
Leqembi is an antibody drug from Eisai and partner Biogen that was found to slow cognitive decline in study volunteers by 27% compared with a placebo over 18 months. Alzheimer’s doctors and researchers have been looking for the arrival of a new therapy that could slow the march of the memory-robbing disease, after years of setbacks hunting for drugs that would actually work.
Does Leqembi work, and how?
The study found that Leqembi helps, but only modestly, according to Alzheimer’s researchers and doctors. The 27% decline was statistically significant, but may not make a meaningful difference for all patients, some doctors said. Meantime, the drug’s use raised the risk of side effects including brain swelling and bleeding.
Leqembi is infused intravenously. What it does is remove from the brain the buildup of sticky tangles called amyloid. Many brain scientists suspect that amyloid buildup plays a role in Alzheimer’s, though researchers haven’t agreed what that role is.
Should I take Leqembi?
Given the risks, some doctors said they would need to discuss with patients whether the upside of modest efficacy is worth the potential harms, including brain swelling and bleeding. Doctors expect many patients and families will want to take the drug, if they can, because it has been so challenging to find anything that works and the disease is so devastating.
Who is it for?
In the key study testing Leqembi, volunteers had early-stage Alzheimer’s disease, defined as mild cognitive impairment or mild dementia, and excessive levels of brain amyloid confirmed with a positron-emission tomography (PET) scan or spinal tap. Patients studied ranged from 50 to 90 years of age, and on average were about 71. Doctors say that multiple factors will determine whether someone is a good candidate for the drug, including other medications they take and how physically healthy they are.
Eisai said it will sell Leqembi at a price of $26,500 a year for the average patient, and that it would be available commercially by Jan. 23.
Will insurance pay for it?
Insurance coverage will probably be hard, at least initially. A big obstacle is a guideline from the Centers for Medicare and Medicaid Services, which provide health insurance to many elderly people with Alzheimer’s. The agency limited use of amyloid-lowering therapies such as Aduhelm, an older drug from Biogen and Eisai that many doctors and researchers said hadn’t been proven to work. Under the guidelines, CMS said it would only pay for people who took an amyloid-lowering drug in a government-approved trial. The agency may reconsider its rule now that an effective drug is approved, but we don’t know when it would make a decision.
Are there other drugs coming?
Drugmakers and researchers are working on dozens of potential drugs. Next up for approval is another amyloid-reducing antibody drug, called donanemab, from Eli Lilly & Co. In a small, mid-stage trial, donanemab also modestly slowed the cognitive decline of study subjects compared with placebo.
As of early 2022, there were 143 drugs in clinical trials for Alzheimer’s disease, including 31 drugs in Phase 3, typically the last stage of testing before a drug can be approved, according to a report in Alzheimer’s & Dementia: Translational Research and Clinical Interventions.
