FDA wants Alexion to clean up
Alexion Pharmaceuticals has run afoul of the FDA. Again. The Wall Street Journal reports that FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices that need to be fixed through efforts such as “enhanced training around gowning procedures, more frequent environmental monitoring,” and other changes to literally clean things up.
The WSJ notes that Alexion asserted in a Securities and Exchange Commission filing that addressing the FDA's concerns won't hurt its financial status. The Journal also notes that this latest report is part of a larger string of citations, which have included a March 2013 warning letter and a bad review after a 2012 inspection.
Soliris costs around $450,000 a year and is indicated for patients with paroxysmal nocturnal hemoglobinuria. The condition destroys red blood cells.