Alexion's C5 complement inhibitor Soliris (eculizumab) clears FDA March 16 for treatment of the orphan blood disorder paroxysmal nocturnal hemoglubinuria. The biologic carries a wholesale acquisition cost of $389,000 per year. Alexion is launching the product with a treatment support service (titled OneSource) with case managers to help facilitate reimbursement. During a March 26 conference call, President David Keiser maintained that "this cost is comparable to the cost of other medicines for disabling and life-threatening ultra-orphan diseases, which are often dosed by weight." Alexion, however, is not resting on its laurels with the PNH claim: the firm is running the EXPLORE patient identification program for blood cell production disorders and recently said it is considering a similar program for the thrombosis market (1Pharmaceutical Approvals Monthly March 2007, p. 4)...

A development partnership between Alexion and Procter & Gamble could be called into question following negative results of two Phase III trials of the terminal complement inhibitor pexelizumab

FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.