Posted by Michael Wonder on 20 Jun 2019
U.S. FDA accepts supplemental biologics license application for Ultomiris (ravulizumab-cwvz) under priority review for the treatment of atypical haemolytic uremic syndrome
20 June 2019 - FDA sets target action date of 19 October 2019.
Alexion Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the company’s supplemental biologics license application for Ultomiris (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, for the treatment of people with atypical hemolytic uremic syndrome (aHUS) in order to inhibit complement-mediated thrombotic microangiopathy (TMA).
The application is based on previously announced results, which were recently presented at the European Renal Association – European Dialysis and Transplant Association Congress, from the Phase 3 study of Ultomiris in people with aHUS, which met the primary endpoint of complete TMA response, defined by haematologic normalisation and improved kidney function.
