Biogen/Eisai Hit ‘Send’ On High Stakes BLA For Aducanumab In Alzheimer’s Disease

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.

Sending email. gesture of finger pressing send button on a computer keyboard
The aducanumab BLA was sent with a request for priority review • Source: Shutterstock

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