AAIC 2021 | Donanemab: breakthrough therapy designation based on TRAILBLAZER data

Aducanumab, donanemab, lecanemab, and gantenerumab are members of a class of monoclonal antibodies that enter the brain at low concentrations and bind to amyloid plaques. Stephen Salloway, MD, MS, of Warren Alpert Medical School of Brown University, Providence, RI, discusses the recent FDA Breakthrough Therapy designation for donanemab, based on clinical data from the TRAILBLAZER-ALZ trial (NCT03367403). Dr Salloway highlights innovations in the conduction of the Phase III trial, including the use of tau PET and response-driven treatment discontinuation. Dr Salloway suggests that there could be two phases to donanemab treatment: an induction phase where treatment is given often to significantly reduce amyloid plaques, followed by a reduced dose maintenance phase. This interview took place during the Alzheimer’s Association International Conference (AAIC) 2021.