Alexion's Soliris wins US priority review in hemolytic uremic syndrome
This article was originally published in Scrip
Executive Summary
The US FDA granted a six-month priority review to Alexion Pharmaceuticals' supplemental biologics license application (sBLA) for Soliris (eculizumab), a first-in-class terminal complement inhibitor, as a treatment for patients with atypical hemolytic uremic syndrome (aHUS), a chronic, ultra-rare disease characterized by the formation of blood clots in small blood vessels throughout the body.