Biogen has withdrawn its application for aducanumab to be approved as a treatment for early Alzheimer's disease by Swissmedic, the Swiss licensing and supervisory authority. In a recent announcement, Biogen also notified the European Medicines Agency (EMA) about the withdrawal of its marketing authorisation application for aducanumab for the treatment of early Alzheimer’s disease, on 22 April 2022. The drug was previously approved in the US by the Food and Drug Administration (FDA), in June 2021. The FDA approval, which was granted via its "accelerated approval pathway", came with specific conditions. Several centres in Switzerland will participate in another study, to further explore the efficacy and safety of aducanumab. Alzheimer Switzerland and Swiss Memory Clinics welcomed this decision which they said "puts patient safety first".
Biogen withdraws application for aducanumab from Swiss licensing and supervisory authority