An About Face As Biogen Says It Will File Aducanumab In Alzheimer’s
Biogen surprised investors with news that it will file aducanumab with the FDA based on data from more patients treated at the highest dose than in the interim futility analysis that led to termination of two Phase III studies in March.
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Given mixed Phase III results for the Alzheimer’s drug and potentially severe side effects for the once-monthly infused therapy, ICER’s recommendation came in below analyst expectations.
Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.
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.