FDA Approves Donanemab for Early Alzheimer's

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Alzheimer's Disease News

Alzheimer Disease,Mild Cognitive Impairment,MCI - Mild Cognitive Impairment

The FDA has approved the anti-amyloid donanemab for early symptomatic Alzheimer's, which includes MCI or mild dementia stage of disease, with confirmed amyloid pathology.

Once-monthly donanemab is"the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions," Eli Lilly said in a statement announcing approval.

"This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer's community," Howard Fillit, MD, co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation , said in the Eli Lilly statement.

In the overall population of patients receiving donanemab, 17% completed treatment at 6 months, 47% at 12 months, and 69% at 18 months on the basis of an assessment of amyloid levels via an amyloid PET.

 

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