FDA to review REMS for Soliris

FDA's Drug Safety and Risk Management Advisory Committee (DSaRM) will meet on Nov. 18 to discuss the REMS for Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN). The committee is seeking public discussion of whether the REMS assures safe use of Soliris without burdening either patient access or the healthcare delivery system.

The humanized mAb targeting complement 5 is approved in the U.S. and EU to treat atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). ...