Posted by Michael Wonder on 19 Oct 2019
Alexion receives FDA approval for Ultomiris (ravulizumab-cwvz) for atypical haemolytic uremic syndrome
18 October 2019 - At 26 weeks, 54% of adults and 71% of children treated with Ultomiris demonstrated complete thrombotic microangiopathy response.
Alexion Pharmaceuticals today announced that the U.S. FDA approved Ultomiris (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric (one month of age and older) patients. This is the first paediatric approval for Ultomiris.
The FDA approval is based on data from two global, single-arm open-label studies of ULTOMIRIS – one in adults and one in children, referred to as paediatrics in the study – with aHUS.
