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.”


Washington, D.C., Jan. 06, 2023 (GLOBE NEWSWIRE) -- "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. 

For people living with Alzheimer’s, every day counts. Lecanemab 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 lecanemab 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."

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

 

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