Biogen Inc

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Eisai Says Initiates Rolling Submission To U.S. FDA For Biologics License Application Of Lecanemab (Ban2401) For Early Alzheimer's Disease

Published: 09/28/2021 00:03 GMT
Biogen Inc (BIIB) - Eisai Initiates Rolling Submission to U.S. FDA for Biologics License Application of Lecanemab (ban2401) for Early Alzheimer's Disease.
Eisai - Lecanemab Clarity Ad Phase 3 Clinical Trial in Early Ad is Ongoing & Completed Enrollment in March 2021 With 1,795 Patients.
Eisai - U.S. FDA Has Agreed That Results of Clarity Ad, When Completed, Can Serve As Confirmatory Study to Verify Clinical Benefit of Lecanemab.
Eisai - Lecanemab Bla Being Submitted Under Accelerated Approval Pathway & Based on Clinical, Biomarker, Safety Data From Phase 2b Clinical Trial.
Eisai - Blinded Safety Data From Clarity Ad Will Be Included to Support Bla of Lecanemab.