Global Alzheimer’s Platform Foundation Statement on FDA Accelerated Approval of Lecanemab

“With this approval, it is incumbent on Center for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure and the drug’s sponsors to offer this life-changing therapy to patients quickly, while prioritizing access and economic fairness.”

Statement attributed to Global Alzheimer’s Platform Foundation President John Dwyer:

Washington, D.C. (Jan. 6, 2023) — We applaud the Food and Drug Administration (FDA)’s decision to grant accelerated approval to lecanemab, a treatment that offers millions of Americans living with Alzheimer’s disease an improved quality of life and will be sold as Leqembi.

For people living with Alzheimer’s, every day counts. Leqembi significantly lowers amyloid plaque buildup in the brain, which means that people on this therapy have a better chance of maintaining a good quality of life.

After reviewing the data, the FDA has clearly identified the clinical benefit, supporting the use of Leqembi as a safe and effective treatment — a life-sustaining treatment — for people living with Alzheimer’s disease.

Patients and their physicians finally have a treatment that can slow the progression of Alzheimer’s disease. With this approval, it is incumbent on Center for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure and the drug’s sponsors to offer this life- changing therapy to patients quickly, while prioritizing access and economic fairness.

The 1.2 million Medicare beneficiaries who are living with Alzheimer’s disease deserve at least that much.

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For Immediate Release:

Contact: Media@GlobalAlzPlatform.org

About the Global Alzheimer’s Platform Foundation (GAP)

The nonprofit Global Alzheimer’s Platform Foundation was founded to speed the delivery of Alzheimer’s treatments with a commitment to promoting diversity in clinical research, as well as lowering the cost and duration of clinical trials to ensure that no one is left behind. As part of its mission, GAP supports more than 100 clinical research sites around the world through study start up and recruitment activities, promoting diversity in research studies, and giving attention to the citizen scientists who make research possible.

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