Alzheimer’s Association Statement on Release of Lecanemab Phase 3 Data

CHICAGO, Sept. 27, 2022 /PRNewswire/ — On behalf of the more than 6 million Americans living with Alzheimer’s disease and their families, the Alzheimer Association enthusiastically welcomes the positive early data reported today by Eisai and Biogen from the CLARITY AD global Phase 3 clinical trial of lecanemab.

These are the most encouraging results from clinical trials investigating the underlying causes of Alzheimer’s disease to date.

For people in the early stages of Alzheimer’s disease, this treatment has the potential to alter the course of the disease in clinically meaningful ways. These results indicate that lecanamab may give people more time to reach or near full capacity to participate in daily life, remain independent, and make future healthcare decisions. Treatments that provide these benefits to people with mild cognitive impairment (MCI) due to Alzheimer’s disease and early-stage Alzheimer’s dementia are just as valuable as treatments that prolong the lives of people with other terminal illnesses.

We look forward to hearing more about the CLARITY AD data at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting in November, including data on safety and participant representation. If this data is consistent with what we’ve seen today regarding efficacy and safety, we strongly support FDA approval and comprehensive coverage.

The Centers for Medicare and Medicaid Services (CMS) recently implemented a nationwide coverage determination (NCD) for amyloid-directed monoclonal antibodies for the treatment of Alzheimer’s disease. As it stands, this NTM would significantly limit Medicare coverage for lecanemab if it is approved for use by the Food and Drug Administration (FDA). CMS is committed to acting quickly to modify the CRS if warranted by new evidence. If CLARITY AD’s full results are consistent with today’s key announcement and the FDA approves this treatment, Medicare beneficiaries living with terminal and progressive Alzheimer’s disease deserve the same immediate coverage. and comprehensive under Medicare available to people with other terminal illnesses.

Even with the success announced today, we must redouble our efforts to discover new targets and test new and more effective treatments for Alzheimer’s disease and all other dementias. The Alzheimer’s Association has long been committed to advancing all potential treatment pathways, and explore methods for combining various approaches in combination therapies. We must also continue to advocate to ensure access to all approved treatments and quality care and support for all.

About the Alzheimer’s Association

The Alzheimer’s Association is a worldwide voluntary health organization dedicated to the care, support and research of Alzheimer’s disease. Our mission is to lead the way to ending Alzheimer’s disease and all other forms of dementia by accelerating global research, promoting risk reduction and early detection, and maximizing the quality of care and support. Our vision is a world without Alzheimer’s disease and all other dementias®. Visit alz.org or call 800.272.3900.

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SOURCE Alzheimer Association