Biogen to Present Data from ADUHELM and Alzheimer’s Disease Portfolio at 2021 Alzheimer’s Association International Conference

CAMBRIDGE, Mass., July 23, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. The company’s contributions to AAIC will include several presentations highlighting data on ADUHELM (aducanumab-avwa) injection 100 mg/mL solution, which was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a treatment for Alzheimer’s disease, as well as its broader Alzheimer’s disease portfolio and research in the field.

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).

Data presentations on ADUHELM will include presentations on multiple topics, including results of an analysis of the PRIME, EMERGE and ENGAGE studies on the correlation between reductions in biomarkers of Alzheimer’s disease and clinical decline after treatment with ADUHELM. The company’s contributions to the congress include four presentations on ADUHELM data and a total of 11 abstracts.

The company will also lead a late-breaking presentation on the design of the real-world observational Phase 4 study in Alzheimer’s disease, a prospective registry of ADUHELM, called International Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE AD-US). ICARE AD-US is focused on collecting real-world, long-term effectiveness and safety data on ADUHELM.

Biogen’s commitment to generate new data about ADUHELM includes three components: the ICARE AD study, the ongoing redosing study, EMBARK, for eligible patients previously enrolled in aducanumab trials, and the upcoming confirmatory, controlled Phase 4 trial that is part of the post-marketing requirement in connection with ADUHELM’s accelerated approval.