In its 21 October press release, Biogen disclosed that it had submitted a European Medicines Agency Marketing Authorisation Application (MAA) for Aducanumab, a monoclonal β-amyloid antibody that has been evaluated in several Phase 2 and 3 clinical trials on mild Alzheimer’s disease and mild cognitive impairment. On 30 October, Biogen and Eisai announced that the European Medicines Agency (EMA) had accepted the MAA for review following a standard timetable.
Aducanumab will now be evaluated by the EMA’s Committee for Medicinal Products for Human Use (CHMP), a process that can take up to 210 days. If the CHMP issues a favourable scientific opinion, the European Commission will then decide whether to grant a marketing authorization for the drug, which would be valid in all EU and EEA-EFTA states. Aducanumab is currently under priority review at the US Food and Drug Administration (FDA), with an FDA advisory committee meeting due to take place on 6 November.
