On Friday, April 22nd, 2022, Biogen announced that it had withdrawn the marketing application in the EU for aducanumab (Aduhelm), its monoclonal antibody that targets aggregated forms of amyloid beta found in the brains of Alzheimer’s patients.

In June, Windrose’s Elizaveta Tchebaniouk provided an analysis of Aduhelm’s approval in Alzheimer’s Disease (AD) and the dynamic environment surrounding Biogen’s launch in the US. High unmet need, uncertain evidence, modest clinical benefit, and affordability concerns continue to make for a highly complex commercial launch.

On June 7th, the FDA granted accelerated approval for Biogen’s amyloid beta-directed anti-body Aduhelm (aducanumab), the first potentially disease-modifying treatment and first approval for Alzheimer’s disease (AD) in nearly two decades.