EU Aduhelm Filing: Biogen Faces Second High-Stakes Meeting At EMA
Executive Summary
Biogen needs to explain why its Alzheimer’s disease drug should be approved in the EU, after the European Medicines Agency rejected the product last year.
You may also be interested in...
Biogen Pulls EU Filing For Aduhelm But Stands By Alzheimer’s Drug
The marketing application was withdrawn before the European Medicines Agency had finished re-examining its earlier recommendation to reject the drug.
Novel Sickle Cell Treatment Among 13 New Drugs On Track For EU Approval
A first-of-its-kind drug for uterine fibroids and a new monoclonal antibody treatment for COVID-19 are among several new drugs recommended for pan-EU approval this month.
EMA Schedules High-Stakes Oral Explanation Meeting For Aducanumab Filing
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.