Biogen’s Aducanumab Falls Hard At Panel Review, Leaving US FDA In A Tight Spot
Successful EMERGE trial does not provide substantial evidence of efficacy in Alzheimer’s because it cannot be divorced from its unsuccessful sister study, advisory committee says; panel’s unequivocal rejection leaves agency’s Office of Neuroscience in a tight spot given its strong support for the drug and the help it gave Biogen to get this far.
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Peripheral and Central Nervous System Drugs Advisory Committee has held two of FDA’s most closely watched meetings in recent years, but there was little overlap between the panel that reviewed Amylyx’s ALS drug and the one that evaluated Biogen’s aducanumab 16 months earlier.
Citing numerous concerns about design of the Phase II CENTAUR trial and statistical robustness of the results, agency reviewers question whether a single study provides substantial evidence of efficacy for approval of AMX0035.
Lilly’s Alzheimer’s Drug Will Get ‘Easier Ride’ Than Aduhelm But Does Not Show Clinical Benefit, Prof Says
Harsh assessment of Lilly’s Phase II study by UCL and UCSF professors suggests donanemab may face same hurdles as Biogen’s Aduhelm. Lilly exec says the drug slowed disease progression by six months, but UCL prof says that won’t make a difference.