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Leqembi Label Recommends Alzheimer’s Patient Registry: A Nod To Medicare Evidence Demands?

 
• By Cathy Kelly

FDA-approved language recommending ongoing patient monitoring through a registry is unusual but not unprecedented to address potential safety concerns.

Registries Face Challenges Recruiting Diverse Set Of Patients • Source: Shutterstock

Labeling for Eisai Co., Ltd./Biogen, Inc.’s new Alzheimer’s drug Leqembi (lecanemab) encourages patient enrollment in the Alzheimer’s Association’s recently launched patient registry, known as Alz-Net, which could provide a framework for collecting the kind of evidence on a voluntary basis that Medicare is mandating in its coverage policy for Alzheimer’s drugs.

Leqembi was approved by the US Food and Drug Administration on 6 January using the agency’s accelerated pathway. It is...

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