Biogen will seek approval of aducanumab, an investigational human monoclonal antibody that targets amyloid beta, for the treatment of early Alzheimer disease. Previously, the Company had announced that it would discontinue the clinical program based on disappointing results of a futility analysis. 

The decision to pursue regulatory approval came after consultation with the Food and Drug Administration (FDA) regarding new data from the phase 3 EMERGE study which showed favorable outcomes with aducanumab. Results from the larger dataset demonstrated that compared with placebo, high dose aducanumab was associated with significant reduction of clinical decline in patients with early Alzheimer disease, as measured by the change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at 78 weeks (primary end point; 23% vs placebo, P =.01).

As for the secondary end points, patients treated with high dose aducanumab showed a consistent reduction of clinical decline as measured by the Mini-Mental State Examination score (15% vs placebo, P =.06), the Alzheimer Disease (AD) Assessment Scale-Cognitive Subscale (13 Items) (27% vs placebo, P =.01), and the AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (40% vs placebo, P =.001). In addition, treatment with low and high dose aducanumab resulted in a reduction in amyloid plaque burden when compared with placebo at 26 and 78 weeks (P <.001). With regard to safety, the most commonly reported adverse events were amyloid-related imaging abnormalities-edema and headache.

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In a press statement, Biogen noted that “the results of the new analysis of the larger dataset and the outcome predicted by the futility analysis was largely due to patients’ greater exposure to high dose aducanumab.” Based on the results of this new analysis, the Company plans to submit a Biologics License Application (BLA) for aducanumab in early 2020. If approved, aducanumab would be the first therapy to reduce clinical decline in patients with early Alzheimer disease.  

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