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EMA Schedules High-Stakes Oral Explanation Meeting For Aducanumab Filing

 
• By Neena Brizmohun

The sponsors of aducanumab and three other drugs are set to explain why their EU marketing authorization applications merit approval during oral explanation meetings at the European Medicines Agency.

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Aducanumab is at the latter stages of the EMA's regulatory review cycle • Source: Alamy

Aducanumab, the Alzheimer’s disease drug from Biogen and Eisai that was controversially approved in the US in June, is among four products nearing the end of the EU marketing review cycle that the European Medicines Agency has scheduled for an oral explanation meeting this week.

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