Alexion announced that the FDA has granted Orphan Drug designation to Soliris (eculizumab), a first-in-class terminal complement inhibitor for the prevention of delayed graft function (DGF) in renal transplant patients.
DGF is an early and serious complication of organ transplantation, characterized by the failure of a transplanted organ to function normally immediately following transplantation. In patients undergoing a kidney transplant, DGF leads to the patient requiring dialysis in order to survive.
Alexion plans to initiate a single multinational DGF registration study with Soliris later this year.
Soliris is already approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
For more information call (888) SOLIRIS or visit Soliris.net.