WASHINGTON (dpa-AFX) - Alexion Pharmaceuticals, Inc. (ALXN) Wednesday said the European Commission has granted an orphan drug designation or ODD to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of graft rejection following solid organ transplantation.
Graft rejection can cause severe injury to the transplanted organ and is a significant barrier to successful transplantation.
Soliris is currently approved in the U.S., European Union, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome - two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.
Alexion is investigating Soliris for the prevention of acute antibody-mediated rejection in kidney transplant recipients, and for the prevention of delayed graft function in patients receiving deceased donor kidney transplants.
Soliris is not approved in any country to prevent or treat rejection following kidney or other solid organ transplantation.
Copyright RTT News/dpa-AFX