Tuesday, June 29, 2021

Very Brief Blog: FDA Posts Still More Aduhelm Documents

 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