Alexion : EU Approves Ultomiris To Treat Atypical Hemolytic Uremic Syndrome

(RTTNews) - Alexion Pharmaceuticals Inc. (ALXN) said that the European Commission has approved Ultomiris for the treatment of adults and children with a body weight of 10 kg or above with atypical hemolytic uremic syndrome or aHUS who are complement inhibitor treatment-naïve or have received SOLIRIS for at least three months and have evidence of response to eculizumab.

Atypical HUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. Atypical HUS affects both adults and children and many patients present in critical condition in the hospital setting, often requiring supportive care, including dialysis, in an intensive care unit.

The U.S. Food and Drug Administration approved Ultomiris for the treatment of aHUS to inhibit TMA for adult and pediatric (one month of age and older) patients in October 2019.