On 17 November, Biogen and Eisai announced that they received a negative trend vote on the marketing authorisation application for aducanumab for the treatment of Alzheimer’s disease (AD) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
This follows an oral explanation held at the November meeting of the CHMP. The CHMP committee plays a vital role in the authorisation of medicines for human use in the European Union. The CHMP is expected to adopt a formal and final opinion on the marketing authorisation application at its next meeting to be held on 13-16 December, 2021. Biogen remains committed to continuing its engagement with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to people with AD in Europe. Aducanumab, a monoclonal β-amyloid antibody, has been evaluated in several trials on mild cognitive impairment and mild AD. It has been conditionally approved for use by the US Food and Drug Administration (FDA) in June 2021.
