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.
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Merck & Co. Eyes Neuroscience Advancement With US FDA’s New Receptivity To Biomarkers
Company is ‘anxious to understand’ how to utilize the agency’s views on importance of biomarkers, exec notes in earnings call. Merck & Co. and Pfizer advance COVID-19 therapeutics into Phase III. Pfizer is awaiting FDA risk-benefit assessment of JAK-1 inhibitors Xeljanz and abrocitinib.
Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says
Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’
US FDA’s Woodcock Rejects Firewall Between Presubmission Advice And Application Review
Public Citizen proposal that FDA staff who provide presubmission advice on a development program not be involved in reviewing the subsequent product application would cause significant public health repercussions and delay drug development, acting commissioner says; Public Citizen had cited ‘close collaboration’ between the FDA and Biogen on aducanumab in calling for the separation.