EISAI/BIOGEN ANNOUNCE TOPLINE RESULTS FROM PHASE 3 TRIAL OF LECANEMAB
“These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date. “
Alheimer’s Association
On Tuesday, September 27, Eisai and Biogen announced positive topline results from their Phase 3 CLARITY AD clinical trial of lecanemab (BAN2401), an anti-amyloid monoclonal antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia. The company stated the trial met all primary and secondary endpoints, and slowed the rate of cognitive decline by 27 percent.
After the announcement, the Alzheimer’s Association issued the following statement. “On behalf of the more than 6 million Americans living with Alzheimer’s disease and their families, the Alzheimer’s Association enthusiastically welcomes the positive topline data reported today by Eisai and Biogen on the CLARITY AD global Phase 3 clinical trial of lecanemab.
“These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date. For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. Treatments that deliver these benefits to those with mild cognitive impairment (MCI) due to Alzheimer’s disease and early Alzheimer’s dementia are just as valuable as treatments that extend the lives of those with other terminal diseases.
“We look forward to learning more about data from CLARITY AD at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting in November, including data on participant safety and representation. If those data are consistent with what we saw today regarding efficacy and safety, we strongly support FDA approval and full coverage.
“The Centers for Medicare and Medicaid Services (CMS) recently implemented a National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. As it stands, this NCD would severely limit Medicare coverage for lecanemab if it is approved for use by the Food and Drug Administration (FDA). CMS has pledged to move quickly to modify the NCD if warranted by new evidence. If full CLARITY AD results are in line with today’s topline announcement and the FDA approves this treatment, Medicare beneficiaries living with Alzheimer’s, a terminal, progressive disease, deserve the same immediate, full coverage under Medicare afforded to those with other terminal diseases.
“Even with the success announced today, we must redouble efforts to discover new targets and test new and more effective treatments for Alzheimer’s and all other dementia. The Alzheimer’s Association has long been committed to advancing all potential treatment avenues and exploring methods for combining diverse approaches into combination therapies. We also must continue to advocate to ensure access to any approved treatments, as well as quality care and support for all people.”
For the Alzheimer’s Disease Facts and Figures, an annual report released by the Alzheimer’s Association please visit alz.org/facts. Support and information from the Alzheimer’s Association are available for free anytime, day or night for individuals with Alzheimer’s disease and their caregivers at 800.272.3900.
