Biogen's aducanumab achieving modest benefit in Phase III EMERGE would support FDA approvability in Alzheimer's, but baseline, subgroup data needed before such calls can be made, experts say

06 Nov 2019

If Biogen’s (NASDAQ:BIIB) aducanumab reports even a 0.2–0.3 effect size in the Phase III EMERGE study primary endpoint, it could help assuage efficacy reservations in Alzheimer’s disease (AD), investigators said. However, it is currently hard to gauge if aducanumab is able to do so as data detail is scarce, four investigators and a biostatistician said, with the company only releasing the trial’s clinical dementia rating—sum of boxes (CDR-SB) endpoint’s percentage changes.

The investigators interviewed by this news service said they’ve only been shown publicly available percentage results, and so are calling for additional baseline information, subgroup data and statistical model information to put percentage data into context. Biogen announced it will be present at the Clinical Trials on AD (CTAD) meeting on 4–7 December in San Diego, California.

While a 0.2–0.3 effect size is considered modest, it could still be enough of an efficacy signal to support FDA approval, should it be statistically significant, due to unmet need in AD, investigators added.

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