Biogen, Inc.’s successful EMERGE study can stand on its own as pivotal efficacy evidence for the Alzheimer’s disease drug aducanumab despite the negative results from a second Phase III trial, the US Food and Drug Administration said.
Biogen’s Aducanumab: One Positive Phase III Trial Is Good Enough For Demonstrating Efficacy, US FDA Says
Negative results from the Phase III ENGAGE trial – which may have been influenced by imbalance in ‘rapid progressors’ and differential effects of dosing protocol changes – do not negate persuasiveness of positive results from the EMERGE study, agency says in advisory committee briefing document; statistical reviewers dissent, call for a new trial of the Alzheimer's drug.
