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Biogen expects to complete the FDA filing for its AD drug aducanumab in Q3

Wednesday 22 April 2020

On 22 April, the biotechnology company Biogen presented its first-quarter earnings report for 2020. One of the announcements was that it would complete its Food and Drug Administration (FDA) filing for its Alzheimer’s disease (AD) drug aducanumab in the third quarter of the year. In March 2019, Biogen announced the discontinuation of its global Phase III clinical trials, ENGAGE and EMERGE, of aducanumab in people with mild cognitive impairment due to AD and mild AD dementia. The decision to halt the trials was based on results from a futility analysis conducted by an independent data monitoring committee, which reported that the trials were unlikely to meet their primary endpoint. However, in October 2019, the company announced plans to pursue regulatory approval for the drug. The Phase III EMERGE trial met its primary endpoint, showing a significant reduction in clinical decline. Findings were presented at the CTAD conference in December 2019.

Biogen provided an update on its aducanumab drug. It has participated in several meetings and continues to have constructive engagement with the FDA. It has an open Biological Licence Application with FDA and expects to complete the filing in the third quarter, despite a previous expectation that it would complete the filing in the first half of this year. In March 2020, the first US research participant was re-dosed in the Phase III EMBARK study, which aims to provide access to aducanumab to eligible participants who were previously enrolled in aducanumab clinical studies such as EMERGE and ENGAGE.