Alexion pharmaceutical: awarded the title of soliris orphan drug by FDA
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Last Update: 2014-01-22
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Source: Internet
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Author: User
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Source: China Association for the promotion of drugs January 22, 2014 Eastern time January 21, 2014 morning, alexion pharmaceutical announced that the U.S Food and Drug Administration (FDA) agreed to award the title of soliris (ekuzumab) orphan drug Soliris is the first level terminal complement inhibitor, which is used to prevent delayed recovery (DGF) of renal transplant patients DGF is a serious complication in the early stage of organ transplantation, which is characterized by failure immediately after organ transplantation In patients undergoing kidney transplantation, DGF results in the need for dialysis to survive Soliris is currently approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two extremely rare and life-threatening serious diseases caused by chronic uncontrolled complement activation disorders Soliris has not been approved in any country for the prevention or treatment of DGF for kidney or other organ transplantation Alexion said it plans to launch a single clinical study of soliris's multinational DGF registry later this year Alexion expects to work closely with the FDA to gather the clinical evidence needed to support the approval of the indication Original link: http://
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