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Biogen : Late-Breaking AAIC Presentation Explores Potential Clinical Effects Of Lecanemab (BAN2401)


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TOKYO, July 29, 2021 /PRNewswire/ Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, Eisai ) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, Biogen ) today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects with early Alzheimer s disease (AD) (Mild Cognitive Impairment [MCI] due to AD and mild AD) at the Alzheimer s Association International Conference (AAIC) held in Denver, Colo., United States and virtually from July 26 to 30, 2021 (Presentation No.: 57780). ....

United States , United Kingdom , Haruo Naito , Charles Weissmann , Walter Gilbert , Heinz Schaller , Michel Vounatsos , Alfred Sandrock Jr , Allison Parks , Mike Hencke , Lynn Kramer , Kenneth Murray , Head Of Research , Alzheimer Association International Conference , Prnewswire Eisai Co Ltd , Investor Relations Department , National Institute On , Biogen Inc , Public Relations Department , National Institutes Of Health , Drug Administration , Eisai Inc , Exchange Commission , Eisai Co Ltd , Neurology Business Group , Alzheimer Clinical Trial Consortium ,

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. ....

United States , Ivana Rubino , Harald Hampel , Eisai Co Ltd , Neurology Business Group , Alzheimer Association International Conference , Eisai Inc , Drug Administration , African American , Association International Conference , African Americans , White Americans , Global Head , Vice President , Chief Medical Officer , ஒன்றுபட்டது மாநிலங்களில் , ஹரால்ட் ஹ்யாஂபெல் , ேசை இணை லிமிடெட் , நரம்பியல் வணிக குழு , முதுமறதி சங்கம் சர்வதேச மாநாடு , ேசை இன்க் , சங்கம் சர்வதேச மாநாடு , வெள்ளை அமெரிக்கர்கள் , உலகளாவிய தலை , துணை ப்ரெஸிடெஂட் , தலைமை மருத்துவ அதிகாரி ,