Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease

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[{"type":"text","content":"CAMBRIDGE, Mass., March 16, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease. The publication includes results from the primary, secondary and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies. In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ADUHELM as the first Alzheimer’s disease treatment to address a defining pathology of the disease. ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). “We are pleased that the peer-reviewed manuscript is now available to provide physicians with a greater understanding of the appropriate use of ADUHELM,” said Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration Development at Biogen. “We will continue to provide physicians with efficacy and safety data to help them make the best treatment decisions for patients as we learn from our ongoing trials and real-world evidence.” “The peer reviewed publication of these data is a testament to the importance of the findings for the scientific and Alzheimer’s disease communities,” said Dr. Paul Aisen, MD., Alzheimer Therapeutic Research Institute, University of Southern California, San Diego. “Alzheimer’s disease is an incredibly complex condition, and this dataset is critical to advancing the understanding of the Phase 3 results.” The publication may be accessed on the JPAD’s website, here. About ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous useADUHELM is indicated for the treatment of Alzheimer’...

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