In a research field grappling with many hurdles, a new drug is showing promise for slowing Alzheimer’s disease.
Based on preliminary studies, the Food and Drug Administration approved Eisai Co. and partner Biogen Inc. SE has just approved lecanumab, which has been shown to reduce a sticky plaque, or amyloid, in the brains of people with early-stage Alzheimer’s. Companies will sell it under the brand name Leqembi.
It is the second drug approved by the agency after Biogen’s Adhelmin to treat brain amyloid.
Here’s what you need to know about Lakenby, and whether you’ll be able to get and pay for it:
Which is the newly approved drug?
Leqembi is an antibody drug from Eisai and partner Biogen that was found to slow cognitive decline by 27% in study volunteers compared to a placebo over 18 months. Alzheimer’s doctors and researchers are looking to the advent of a new therapy that could slow the march of the memory-robbing disease after years of faltering in the hunt for drugs that actually work.
Does Leqembi work, and how?
According to Alzheimer’s researchers and doctors, the study found that lekenbi helps, but only modestly. Some doctors said the 27% drop was statistically significant, but may not make a meaningful difference for all patients. Meanwhile, use of the drug carried an increased risk of side effects, including swelling and bleeding in the brain.
Lekembi is given intravenously. What it does is remove a build-up of sticky tangles called amyloid from the brain. Many brain scientists suspect that amyloid buildup plays a role in Alzheimer’s, although researchers do not agree on what that role is.
Should I be taking Lekembi?
Given the risks, some doctors said they would need to discuss with patients whether the upside of modest efficacy is worth the potential harms, which include brain swelling and bleeding. Doctors expect that many patients and families will seek the drug, if they can, because it’s so challenging to find anything that works and the disease is so devastating.
what’s that for?
In the lead study testing LEKEMBI, 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 Had happened. Patients ranged in age from 50 to 90, and were about 71 on average. Doctors say several factors will determine whether someone is a good candidate for the drug, including other medications they are taking and how physically healthy they are.
Eisai said it will sell Leqembi at a cost of $26,500 per year for the average patient, and it will be commercially available by January 23.
Will insurance pay for it?
Insurance coverage will probably be difficult, at least initially. A major hurdle is guidelines from the Centers for Medicare and Medicaid Services, which provides health insurance to many elderly people with Alzheimer’s. The agency limited the use of amyloid-lowering therapies such as EduHelm, an older drug from Biogen and Christiania, which many doctors and researchers said had not been proven to work. Under the guidelines, CMS said it would pay only for people who took the amyloid-reducing drug in a government-approved trial. The agency may reconsider its rule now that an effective drug has been approved, but we don’t know when it will decide.
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 from Eli Lilly and Company, called donenumab. In a small, mid-stage trial, donanumab also slowed study subjects’ cognitive decline compared to a placebo.
According to a report in Alzheimer’s and Dementia: Translational Research and Clinical Interventions, by the beginning of 2022, there were 143 drugs in clinical trials for Alzheimer’s disease, including 31 drugs in phase 3, usually a drug further from approval. Last step of the first test.