Posted by Michael Wonder on 24 Apr 2022
Update on regulatory submission for aducanumab in the European Union
22 April 2022 - Biogen has notified the EMA of its decision to withdraw its marketing authorisation application for aducanumab for the treatment of the early stages of Alzheimer’s disease.
The company withdrew its application following interactions with EMA’s CHMP indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorisation of aducanumab by EMA.
Biogen’s application had been under review by the CHMP in response to the company’s request for a re-examination of the negative opinion the regulatory body issued in December 2021.
