FDA approves Portola's Bevyxxa betrixaban to prevent VTE

FDA approved an NDA from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) for Bevyxxa betrixaban (PRT054021) to prevent venous thromboembolism (VTE) in hospitalized and post-discharge adults with acute illnesses who are at high risk for complications. The oral Factor Xa inhibitor is the first anticoagulant approved in the indication. It has Fast Track status and was under Priority Review.

The agency based the approval on data from the Phase III APEX trial. Bevyxxa narrowly failed to show superiority to injectable enoxaparin, a low molecular weight heparin, in the study's first cohort. The trial's design specified that Bevyxxa show superiority in that cohort in order to evaluate the primary endpoint in two larger cohorts sequentially. Portola conducted an exploratory analysis showing that the candidate met the superiority endpoint in the larger cohorts and the overall study population (see BioCentury, April 4, 2016 & Feb. 13, 2017)...