Will the US FDA back aducanumab for Alzheimer’s disease?

Written by Sharon Salt, Senior Editor

On Wednesday (4 November), Biogen‘s and Eisai’s stocks both jumped 40% after the US FDA seemingly indicated that aducanumab – Biogen’s Alzheimer’s drug – was sufficiently safe and effective. Documents posted on Wednesday by the FDA have fired up discussions as to whether or not they are preparing to approve the drug, with one of the documents stating that Biogen has shown “robust and exceptionally persuasive” data from a large clinical trial (Study 302). Within the Advisory Committee Briefing Document, the FDA further commented that: “the results of Study 302 are highly persuasive and the study is capable of providing...

To view this content, please register now for access

It's completely free