23 March 2018 - Portola Pharmaceuticals today announced that the CHMP of the EMA has issued a negative opinion for betrixaban for the prevention of venous thromboembolism in adult patients hospitalised for an acute medical illness with risk factors for venous thromboembolism, including venous thromboembolism-related death. 

The Company intends to appeal the opinion and seek a re-examination by the CHMP.

The marketing authorisation application 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.

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