Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer's Disease at AAIC 2021

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- ICARE AD-US is an observational real-world phase 4 study designed to evaluate the safety and effectiveness of ADUHELM in clinical practice
- ICARE AD-US is one of three programs to generate post-approval data on ADUHELM, including the re-dosing Phase 3b EMBARK study and the planned confirmatory Phase 4 post-marketing requirement study
- Biogen aims to enroll at least 16 percent Latinx and Black/African American patients with Alzheimer's disease in the ICARE AD-US study as part of its commitment to increase participation from traditionally underrepresented communities
TOKYO, July 30, 2021 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer's disease called ICARE AD-US, at the Alzheimer's Association International Conference (AAIC), being held both virtually and in Denver, Colorado from July 26 - 30, 2021. ICARE AD-US, a prospective study of ADUHELMTM (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM. The virtual oral session (#57522) was titled, "ICARE AD-US: design of a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in United States."

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