Posted by Michael Wonder on 13 Feb 2023
US FDA approval of drugs not meeting pivotal trial primary outcomes (2018-2021)
13 February 2023 - In June 2021, the US FDA granted accelerated approval to aducanumab for the treatment of Alzheimer disease despite both pivotal trials being stopped for futility with respect to the primary trial outcome: change from baseline clinical dementia rating score.
Instead, FDA approval was based on an exploratory, surrogate marker: amyloid plaque reduction.
