Alexion Pharmaceuticals (ALXN) announced that the U.S. Food and Drug Administration or FDA has granted an orphan drug designation or ODD to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of delayed graft function or 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.
Soliris is currently approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is not approved in any country to prevent or treat DGF following kidney or other solid organ transplantation.
Alexion said it plans to initiate a single multinational DGF registration study with Soliris later this year. Alexion looks forward to working closely with the FDA to gather the clinical evidence needed to support approval for this indication.
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December 12, 2025 15:14 ET Central bank decisions dominated the economic news flow this week led by the Federal Reserve. Trade data from the U.S. also gained attention. The Canadian and Swiss central banks also announced their interest rate decisions. Inflation data from China was in focus as the country released the latest consumer price and producer price data.