BrightFocus Foundation is encouraged by the positive topline results issued on the global Phase 3 clinical trial of Alzheimer’s drug lecanemab, which was reported to slow cognitive decline among people with Alzheimer’s disease.
The findings are the first to show a statistically significant decrease in cognitive issues by targeting amyloid, a protein expressed in many different organ systems.
The data, said Jim Taylor, president of Voice of Alzheimer’s, is another powerful sign of progress in the development of disease-modifying treatments for Alzheimer’s and additional evidence that the Centers for Medicare and Medicaid Services must rethink its blanket refusal to cover the new drugs.
“The companies described their test results as highly statistically significant,” said Taylor. “They are also politically significant. Based on these results, we will demand that the federal government change its unfair policies on coverage of Alzheimer’s treatments.”
Eisai and Biogen reported lecanemab reduced cognitive decline by 27 percent through the removal of aggregated amyloid-beta (Aβ ) in the brains of people who received it (nearly 2,000 participants) compared to a placebo.
When amyloid gets misprocessed and accumulates, it causes neurodegeneration. A healthy brain can break down amyloid-beta and eliminate it, but in Alzheimer’s disease, Aβ forms insoluble plaques that are toxic to neurons and sometimes associated with memory loss and other changes.
“BrightFocus Foundation is excited for a potential new treatment that could slow the progression of Alzheimer’s disease and improve quality of life for the millions of people it devastates,” said Stacy Pagos Haller, President and CEO, BrightFocus Foundation, in a news release. “Our team of expert Alzheimer’s disease researchers are actively exploring multiple scientific pathways that have the most promise to end Alzheimer’s; we won’t stop until there’s a cure.”
Eisai will present the study results on Nov. 29 at the Clinical Trials on Alzheimer’s Congress and stated that findings will be published in a peer-reviewed medical journal soon.
Eisai applied for accelerated FDA approval of the drug based on a smaller, earlier-stage clinical trial and said they will now submit the new trial results to the FDA. A decision on the drug should be made by early next year.
Voices of Alzheimer’s strongly urged the FDA to give prompt consideration of the newest data and urged speedy approval of the drug, according to a news release from the advocacy organization.
“The Alzheimer’s community has been praying for a successful result and our prayers have been answered,” said Terrie Montgomery, a founding board member of Voices of Alzheimer’s who is living with early-onset Alzheimer’s. “We will now turn our attention to our elected leaders and demand that lecanemab and similar treatments, once approved by the FDA, be covered by Medicare and Medicaid to make them accessible to the people who need them.”
Once the FDA makes a decision. the drug would go to the Centers for Medicare and Medicaid for a coverage decision.
“It is our strong belief that Medicare has discriminated against people with Alzheimer’s and their families for the last decade by failing to provide coverage for Alzheimer’s diagnostics and FDA-approved treatments,” said Phil Gutis, a founding VOA Board member and person living with early-onset Alzheimer’s. “All people living with Alzheimer’s and their families must let the government know in no uncertain terms that such discrimination is unacceptable and must end.”
Learn more about the results online at brightfocus.org.
Learn more about Voices of Alzheimer’s and their advocacy efforts at voicesofad.com
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Crystal Graham
