In a landmark decision, on June 7, 2021, FDA approved Biogen's monoclonal drug ADUHELM (aducanumab) for the treatment of Alzheimer's disease. It's an accelerated approval, which is typically based on a surrogate outcome. Here, the surrogate biomarker outcome is amyloid load on PET imaging. This sidesteps the issue of the data for cognitive outcomes in the two pivotal trials, where the data was complex.
- The FDA's basic press release is here.
- FDA released a detailed letter on its decision-making process signed by Dr Patrizia Cavazzoni, CDER, here.
- FDA also posted a two-page letter to its own 2020 advisory committee, here. Signed by Billy Dunn MD, Neuroscience, CDER.
- The FDA label, 22 pages long, is here.
- The 9-page approval letter (including postmarketing information) is here.
- See early press at Forbes here, Reuters here.