Alexion gets pexelizumab SPAs

(ALXN) and partner Procter & Gamble (PG) received Special Protocol Assessments (SPAs) from FDA for two international Phase III trials of pexelizumab, a complement 5 (C5) inhibitor antibody fragment. The PRIMO-CABG2 trial will enroll about 4,000 moderate to high risk patients undergoing coronary artery bypass graft ( CABG) surgery with or without concomitant valve surgery during cardiopulmonary bypass. The primary endpoint will measure composite death or myocardial infarction (MI) at 30 days following CABG surgery. In a previous trial, PRIMO- CABG, the compound missed the primary endpoint, which was the incidence of death or myocardial infarction, measured at 30 days post-procedure, in the subpopulation of patients undergoing CABG without concomitant valve surgery. ...