A new treatment for Alzheimer’s disease was approved by the US Food and Drug Administration on 7 June using a surrogate end point for clinical benefit: a reduction of amyloid beta plaque in the brain. Aduhelm (aducanumab) was given an accelerated approval. It is the first new treatment approved for Alzheimer's disease in the US since 2003.
The approval comes two years after the developers, Biogen Inc and Eisai Co Ltd, stopped two Phase 3 trials of aducanumab for lack of efficacy. They restarted the programme after analysing additional data that suggested a beneficial effect.