Eisai statement on the Centers for Medicare and Medicaid Services’ National coverage determination with coverage with evidence development for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease

Eisai

8 April 2022 - Eisai stands with people living with Alzheimer’s disease and their families, health care professionals and other members of our Alzheimer’s disease community. 

We respect that the CMS has committed to quickly reconsider the National Coverage Determination once an anti-amyloid drug for the treatment of Alzheimer’s disease has met the coverage with evidence development requirements with quality evidence.

Eisai anticipates completing our anti-amyloid-beta protofibril antibody lecanemab’s rolling submission of a biologics license application to the FDA under the accelerated approval pathway in the first quarter of our fiscal year 2022, which began 1 April 2022.

Read Eisai press release

Michael Wonder

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Michael Wonder

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Medicine , US , Market access