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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Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.
The company remains confident in US FDA approval for the first disease-modifying Alzheimer’s drug based on current data, but Biogen needs more time to complete the BLA filing.
As Biogen moves to file its controversial amyloid drug aducanumab for approval in the US, two similar investigational Alzheimer's drugs – Eli Lilly's solanezumab and Roche's gantenerumab – did not slow memory loss or cognitive decline in a rare, inherited form of the disease.