Alexion Pharmaceuticals Inc. (ALXN) Release: FDA Grants Orphan Drug Designation to Soliris® (Eculizumab) For Prevention Of Delayed Graft Function (DGF) In Renal Transplant Patients
1/21/2014 9:30:12 AM
CHESHIRE, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals (Nasdaq:ALXN) today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) 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 that is 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. 1-3
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