Biogen to Seek Approval of Aducanumab for Early Alzheimer’s Based on New Analysis of Trials

Biogen to Seek Approval of Aducanumab for Early Alzheimer’s Based on New Analysis of Trials
Biogen is planning to seek approval for aducanumab, an injectable treatment under investigation for patients with early Alzheimer’s disease, following a new analysis of Phase 3 studies supporting meaningful benefits for patients' cognition and daily life abilities. After meeting with the U.S. Food and Drug Administration (FDA), Biogen plans to submit a Biologics License Application in early 2020. The company is also consulting with other regulatory authorities in other countries, including Europe and Japan. If accepted, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease. The decision came after the analysis of a larger dataset of Phase 3 clinical trials ENGAGE (NCT02477800) and EMERGE (NCT02484547), showing that monthly vein infusions of aducanumab reduced the clinical decline of patients with early Alzheimer's. Both trials were halted in March after a monitoring committee analyzed data from the first 18 months of the studies and determined that aducanumab was not likely to produce meaningful benefits for patients. However, Biogen reconsidered when an additional three months of data became available after the trials were discontinued. The new analysis showed that EMERGE met its primary efficacy measure, or endpoint, with aducanumab resulting in benefits for cognition and function, including memory, orientation, and language, as well as activities of daily living. An important piece of new data showed that a group of patients from ENGAGE who received sufficient exposure to high-dose aducanumab also experienced significant benefits. Biogen believes it was largely due to these patients that the results actually proved more positive than at the time of the trials' halt. In addition, aducanumab was able to re
Subscribe or to access all post and page content.