Posted by Michael Wonder on 23 Nov 2021
Update on regulatory review of aducanumab in the European Union
17 November 2021 - Biogen and Eisai announced today an update on the on-going review of the marketing authorisation application for aducanumab 100 mg/mL concentrate solution for infusion for the treatment of Alzheimer’s disease by CHMP of the EMA.
Following an oral explanation held at the November meeting of the CHMP, Biogen received a negative trend vote on the aducanumab marketing authorisation application.
The CHMP is expected to adopt a formal opinion on the marketing authorisation application at its December meeting (December 13-16, 2021).
