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Statement on JAMA Neurology Publication about Amyloid-Related Imaging Abnormalities in Two Phase 3 Studies Evaluating Aducanumab in Early Alzheimer’s Disease

November 22, 2021 Company Statements

Today, Biogen and Eisai announced that the Journal of the American Medical Association (JAMA) Neurology published a peer-reviewed paper about findings around amyloid-related imaging abnormalities (ARIA) in the Phase 3 trials of ADUHELM (aducanumab-avwa). The publication notes that the importance of the manuscript is, “The EMERGE and ENGAGE phase 3 randomized clinical trials of aducanumab provide a robust data set to characterize amyloid-related imaging abnormalities (ARIA) that occur with treatment with aducanumab, an amyloid-β (Aβ)-targeting monoclonal antibody, in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia.”

The combined studies consisted of a total of 3,285 participants with Alzheimer’s disease who received 1 or more doses of placebo (n=1087) or aducanumab (n=2198; 2752 total person-years of exposure) during the placebo-controlled period.
The complete publication is available on the JAMA Neurology website.

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