Investigational Guillain-Barré Syndrome Treatment Granted FDA Fast Track Designation

September 24, 2019
Drew Boxler

Monoclonal antibody for autoimmune and neurodegenerative disorders.

The FDA has granted a Fast Track Designation to ANX005 for the potential treatment of Guillain-Barré Syndrome. 

ANX005 is a new investigational, monoclonal antibody produced by clinical-stage biopharmaceutical company Annexon Biosciences, intended to treat a variety of autoimmune and neurodegenerative disorders. Administered as an intravenous infusion, the treatment inhibits C1q and the entire classical complement pathway. 

According to a release, the ANX005 recently completed a phase 1b clinical trial and will advance to later-stage clinical trials in Guillain-Barré Syndrome. Annexon says that they will also be trying to develop ANX005 for the treatment of other autoimmune and neurodegenerative diseases as well. 

Fast Track Designations by the FDA expedite the development, review, and protenital approval of investigational product candidates that are intended to treat serious or life-threatening diseases with an unmetn clinical need.