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

 
• By Mandy Jackson

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 request for priority review – six months versus the 10-month standard review – aducanumab approval could be granted as early as the first week of March 2021

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• By Ian Haydock

Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.