FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021. Learn more.
“The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease. We look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and have accompanied us on this journey. We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.”
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 2020, 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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- The FDA has accepted the BLA for aducanumab. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021. The FDA also stated that it is currently planning to hold an Advisory Committee meeting for this application on a yet-to-be-determined date.
- Biogen has continued to engage in dialogue with regulatory authorities in other markets, including in Europe and Japan.
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