Alexion Pharma Says Phase 3 Study Of ULTOMIRIS Meets Primary Objective

(RTTNews) - Alexion Pharmaceuticals Inc. (ALXN) said that the Phase 3 study of ULTOMIRIS (ravulizumab-cwvz), the company's long-acting C5 complement inhibitor, met its primary objective in complement inhibitor-naïve patients with atypical hemolytic uremic syndrome or aHUS.

In the initial 26 week treatment period, 53.6 percent of patients (95% CI [39.6%, 67.5%]) demonstrated complete thrombotic microangiopathy (TMA) response. ULTOMIRIS provided immediate and complete inhibition of the complement C5 protein that was sustained over the entire eight-week dosing interval.

"The results met the high bar of complete TMA response, defined by hematologic normalization and improved kidney function, and provide confidence that ULTOMIRIS has the potential to become the new standard of care for patients with aHUS. We are preparing regulatory submissions for ULTOMIRIS in aHUS in the U.S., European Union and Japan as quickly as possible," said John Orloff, Executive Vice President and Head of Research & Development at Alexion.