BCIQ Profiles

Company Profile Report
1120 aducanumab
BioCentury & Getty Images

Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

Aducanumab’s chances of approval are slim, but they’re not zero. KOLs weigh in on what a path to approval could look like.

Aducanumab’s chances of approval are slim, but they’re not zero. KOLs weigh in on what a path to approval could look like.

Nov 21, 2020 | 4:50 AM GMT

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb has defied gravity before.

FDA’s clear desire to authorize the anti-amyloid agent begs the question of whether a path to market may still exist – and what it would look like.

Aducanumab failed for futility in March 2019 causing Biogen Inc. (NASDAQ:BIIB) to discontinue the two Phase III trials, EMERGE and ENGAGE. Seven months later,  Biogen reported that EMERGE met the primary cognitive endpoint at the study’s last time point of 78 weeks, based on an analysis that modeled data from the nearly 50% of subjects who didn’t complete the study. Investors added $10.6 billion to Biogen’s market cap, taking it to $51 billion on

Read the full 1922 word article

How to gain access

Continue reading with a
two-week free trial.