KOL Views: Reassessing Biogen's aducanumab in light of DMC's immaculate misconception

Biogen and Eisai stopped a pair of Phase III trials (EMERGE and ENGAGE) in March after a data monitoring committee (DMC) conducted an interim futility and said aducanumab was unlikely to meet the primary endpoints to treat Alzheimer's disease (AD). The partners shocked the world this week by claiming that – well, actually – the anti-beta amyloid mAb had succeeded in one of the studies and, with "support" from the FDA, they plan to submit a marketing application for it.

To provide FirstWord readers with rapid feedback on what this may mean for aducanumab and the treatment of AD, we are hosting an expert call with a key opinion leader (KOL) later this week.

Key topics that will be discussed during the call include, among other things… where do you stand on the 'amyloid hypothesis'; has your perspective changed over the last couple years as more pivotal readouts have become available; what was your reaction this spring to the discontinuation of the Phase III trials of aducanumab; what are your initial thoughts now that Biogen has determined – despite the DMC's preliminary conclusion – that aducanumab did in fact meet the primary endpoint in one of the two trials; should one successful Phase III trial (and another that did not meet the primary endpoint) be enough evidence to support approval in AD; given the interim futility analysis and this week's unexpected U-turn, how confident are you about the EMERGE results; how confident are you about aducanumab's profile overall; based on available data, does aducanumab's safety/tolerability profile look sufficiently manageable for use outside of a clinical trial setting; do you think that aducanumab will be approved based on available data; would you prefer a confirmatory study of aducanumab be run prior to or after approval; Biogen and Eisai have yet to reveal patient-level data but if/when it does what would you hope to see that might help convince you that aducanumab is effective; what other data or analyses you are particularly interested in seeing from the EMERGE and ENGAGE trials; and what does this mean for other companies developing therapies targeting beta-amyloid?

Ask the expert!

Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to the amyloid hypothesis, aducanumab and the treatment of AD.

We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.

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As always, FirstWord would very much like to receive your feedback and suggestions.

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