Alexion gets positive CHMP opinion on extended indication for eculizumab The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Soliris. The marketing authorization holder for this medicinal product is Alexion Europe SAS. Soliris is currently authorized for the treatment of paroxysmal nocturnal haemoglobinuria in adults only and atypical haemolytic uremic syndrome in adults and children. The CHMPís opinion now recommends that the PNH indication be extended to include children, the EMA announced.
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Alexion announces EC grants orphan drug designation for Soliris Alexion announced that the European Commission has granted an orphan drug designation to Soliris, a first-in-class terminal complement inhibitor, for the prevention of delayed graft function after solid organ transplantation. 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 kidney transplantation, patients who develop DGF require dialysis in order to survive.