EMA turns down Aduhelm

Friday 17 December 2021
Country

Netherlands

The European Medicines Agency has issued a negative opinion for the Alzheimer’s disease treatment Aduhelm (aducanumab) saying that studies supporting the drug’s application were conflicting and did not show overall effectiveness in treating adults with early stage disease. Under the EU’s regulatory procedures, the sponsor, Biogen, Inc, has 15 days to appeal against the opinion. Aduhelm is an immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against amyloid-beta levels in the brain.