An interim analysis of the small, single-arm ANNEXA-4 study of Portola Pharmaceuticals Inc.'sAndexXa antidote for Factor Xa anticoagulants raised questions about an 18% rate of thrombotic events, but the company explains that this is in line with what would be expected for an at-risk, elderly patient population.
Portola Defends AndexXa Antidote Safety, Says Thrombotic Events In Line
Interim analysis of ANNEXA-4 study published in NEJM supports case for AndexXa approval, but 18% thrombosis rate raised some eyebrows.
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