Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen Inc. and Eisai Co. Ltd.’s decision to move ahead with a BLA submission for aducanumab in Alzheimer’s disease despite mixed clinical results stunned the pharma world, but a look at the history of the Center for Drug Evaluation and Research’s division of neurology products suggests that the application might find reviewers receptive to arguments that look to the totality of the evidence.

The aducanumab BLA will fall short of the gold standard of two well-controlled randomized clinical efficacy trials. Indeed, the Phase III trials, ENGAGE and EMERGE, were discontinued for futility in March 2019