27 June 2019 - Arrowhead Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ARO-AAT, the company’s second generation subcutaneously administered RNA interference therapeutic being developed as a treatment for a rare genetic liver disease associated with alfa-1 antitrypsin deficiency (AATD).
Arrowhead is in final preparations to initiate SEQUOIA (AROAAT2001), a potentially pivotal Phase 2/3 clinical study in the U.S. and Europe, and AROAAT2002, a Phase 2 open-label clinical study in Europe.