On 31 January, the global biotechnology company Biogen announced its decision to discontinue development and commercialisation of aducanumab for early Alzheimer's disease (AD). Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021. The company noted that this decision is not related to any safety or efficacy concerns. The plan is to reprioritise the resources in AD. Biogen, along with partner Eisai, will focus on advancing lecanemab, the first anti-amyloid beta treatment for AD to be granted traditional approval by the FDA.
The drugmaker will also accelerate development of two experimental treatments, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113). Biogen will terminate the ENVISION clinical study, a Phase 4 post-marketing study aiming to confirm the benefit of aducanumab as required by the FDA under its accelerated approval. Biogen licensed aducanumab from Neurimmune and has terminated that license. Biogen will hand back the rights to Neurimmune.