A week ago, FDA posted some internal review documents on the home page for aducanumab (Aduhelm). At that time there were three; now there are a total of six.
These include the full-length review of clinical pharmacology and of statistics. (Pretty long versions were presented at the November 2020 Ad Comm meeting; but these are the "full, final" versions as of June 2021.)
Article at Endpoints here. The FDA home page for ADU is here.
The released FDA documents are these:
FDA Application Review Files
- Office of Neurology's Summary Review Memorandum (PDF)
- Concurrence Memorandum from Peter Stein, MD, Director, Office of New Drugs (PDF)
- Memorandum from Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) (PDF)
- Clinical Pharmacology Review (PDF)
- Medical Review (PDF)
- Statistical Review (PDF)
