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Questions EMERGE as Biogen claims aducanumab turnaround

Nature Reviews Neurology volume 16, pages 63–64 (2020)Cite this article

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Trials of aducanumab in Alzheimer disease were previously discontinued following a phase III futility analysis, but Biogen now says that additional data indicate that longer exposure to the higher dose might be effective. The company is seeking FDA approval for the treatment; however, the limited data released do not establish efficacy.

Biogen’s aducanumab is a human immunoglobulin G1 monoclonal antibody with high affinity for a conformational epitope on aggregated forms of amyloid-β (Aβ). Phase I trial data published in Nature in 2016 showed that treatment with aducanumab removed Aβ from the brain and potentially reduced cognitive decline1. Participants with early Alzheimer disease (AD) were enrolled into two identical phase III trials of the treatment — ENGAGE (started August 2015) and EMERGE (started September 2015). These trials were discontinued in March 2019, when a futility analysis indicated little chance of treatment efficacy2. This decision was based on data from participants who had completed 18 months of follow-up by December 2018, which was approximately half of the total number enrolled. In April 2019, Biogen also shelved a planned phase III secondary prevention trial of aducanumab in AD3, and it seemed this was case closed on yet another promising contender to be the first effective AD-modifying treatment. However, on 22 October 2019, Biogen presented an analysis that was based on more complete data from ENGAGE and EMERGE. In a slide presentation for investors, headlined: ‘Sufficient exposure to high dose aducanumab reduced clinical decline across multiple clinical endpoints’, the company reported that they were making a submission for FDA approval of aducanumab4.

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References

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  1. Division of Psychiatry, University College London, London, UK

    Robert Howard & Kathy Y. Liu

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Correspondence to Robert Howard.

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Howard, R., Liu, K.Y. Questions EMERGE as Biogen claims aducanumab turnaround. Nat Rev Neurol 16, 63–64 (2020). https://doi.org/10.1038/s41582-019-0295-9

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