Biogen Completes Submission of Biologics License Application (BLA) to FDA for Aducanumab as a Treatment for Alzheimer’s Disease
Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer’s disease. The completed submission followed ongoing collaboration with the FDA and includes clinical data from the Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1b PRIME study. Learn more.
“Alzheimer’s disease remains one of the greatest public health challenges of our time. It robs memories, independence and eventually the ability to perform basic tasks from the people we love. The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease. We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing.”
Aducanumab Phase 3 Trials
- In EMERGE, patients who received aducanumab experienced significant slowing of decline on measures of cognition and function such as memory, orientation and language. Patients also experienced slowing of decline on activities of daily living including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. While another Phase 3 trial, ENGAGE, did not meet its primary endpoint, Biogen believes a subset of data from ENGAGE are supportive of the outcome in EMERGE.
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Previously Enrolled Patients
- The global re-dosing study, EMBARK, was initiated in March 2019, in line with our commitment to offer aducanumab to eligible patients who were previously enrolled in aducanumab trials. This is a global re-dosing clinical trial designed to evaluate aducanumab (BIIB037) in eligible Alzheimer’s disease patients who were actively enrolled in aducanumab studies (PRIME, EVOLVE, EMERGE and ENGAGE) in March 2019. We wish to thank all clinical trial participants who have contributed to the development of aducanumab.
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- Biogen completed the submission of a Biologics License Application (BLA) with the FDA on July 8, 2020. The FDA has up to 60 days from that date to decide whether to accept the application for review, at which point, if accepted, Biogen expects the FDA will also inform the Company whether the BLA has been granted Priority Review designation.
- Biogen has continued to engage in dialogue with regulatory authorities globally, including in Europe and Japan, working diligently toward the goal of filing applications in these markets.
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