|Portola Pharmaceuticals Receives and Plans to Appeal Negative CHMP Opinion Regarding Marketing Authorization for Betrixaban in the European Union|
“We believe we have generated substantial evidence which demonstrates the clinically-meaningful benefit of betrixaban in reducing VTE and VTE-related deaths in this vulnerable patient population, and we remain confident in its potential to have a major public health impact,” said
The Marketing Authorization Application (MAA) for betrixaban included data from Portola’s pivotal Phase 3 APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide. The APEX study evaluated oral betrixaban from hospital admission to home (35 to 42 days) compared with injectable enoxaparin for 6 to 14 days followed by placebo in assessing the prevention of VTE in high-risk acutely ill medical patients.
Betrixaban was approved by the
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