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.
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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.
Drugs for COVID-19, Alzheimer’s disease and heavy menstrual bleeding due to uterine fibroids are among the latest products that are this week being considered for marketing approval by the European Medicine Agency’s human drugs evaluation committee, the CHMP.
The EU marketing application for aducanumab is heading for a rejection for Alzheimer’s disease, according to a “negative trend vote” at the CHMP disclosed by the drug’s sponsors.