Skip to main navigation 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. NOVEMBER 17, 2021 Update on Regulatory Review of Aducanumab in the European Union CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced today an update on the ongoing review of the Marketing Authorization Application for aducanumab 100 mg/mL concentrate solution for infusion for the treatment of Alzheimer’s READ MORE NOVEMBER 16, 2021 The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established efficacy and well-characterized safety, building on Biogen’s leadership in MS oral therapies Phase 3 data have demonstrated that treatment with VUMERITY results in low discontinuation rates READ MORE Footer Links Investors Careers News Releases Our Stories Receive Our Updates Contact Us Follow us: Legal Community Guidelines Cookie Policy Forward-Looking Statement Notice to CA Residents Privacy Policy Terms & Conditions © 2021 Biogen