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

 
• By Mandy Jackson
  
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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.

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The aducanumab BLA was sent with a request for priority review • Source: Shutterstock

Biogen and partner Eisai Co. Ltd. said on 8 July that they completed their highly anticipated biologics license application (BLA) submission for the amyloid-beta-clearing monoclonal antibody aducanumab in Alzheimer’s disease, kicking off up to two months of speculation about whether or not the controversial pivotal dataset meets the US Food and Drug Administration’s standards for accepting the application.

The FDA has 60 days to decide whether to accept the BLA and if the agency grants Biogen’s and Eisai’s...

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