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

 
• By Bridget Silverman
  
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Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.

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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...

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