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Biogen announces regulatory filing plan for Aducanumab, based on new analysis of EMERGE and ENGAGE studies

Tuesday 22 October 2019

On 22 October, Biogen announced its plans to seek regulatory approval for Aducanumab, based on a new analysis of a larger dataset from its EMERGE and ENGAGE Phase III studies. These studies were discontinued in March 2019 following a futility analysis of data from 1,748 participants who had completed the 18-month study period. However, Biogen’s new analysis included data that became available after this futility analysis had been completed, bringing that participant number up to 2,066.

The new analysis revealed that the Phase III EMERGE study had met its primary endpoint, showing a significant reduction in clinical decline following administration of Aducanumab to participants with mild cognitive impairment due to AD and mild AD dementia. Aducanumab (BIIB037) is a monoclonal antibody that binds aggregated forms of amyloid-β (Aβ), which accumulates in the brain during the development of AD.  The drug was designed to activate the immune system following binding to Aβ, thereby enabling clearance of these damaging protein aggregates. Participants who were sufficiently exposed to high doses of Aducanumab had reductions in brain Aβ, experiencing significant benefits on measures of cognition and function. Importantly, they also experienced an increased quality of life, with greater ability to conduct their personal finances, perform household chores and travel independently outside the home.

Biogen now plans to file a Biologics Licence Application with the US Food and Drug Administration (FDA) in early 2020, and will continue dialogue with the EU and Japanese drug authorities.

Read Biogen's full press release, here: