CHMP does not recommend Bevyxxa for prevention of venous thromboembolism in adults.- Portola Pharma.
Portola Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for Bevyxxa (betrixaban) for the prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death. The Company intends to appeal the opinion and seek a re-examination by the CHMP.
The Marketing Authorization Application (MAA) for betrixaban included data from Portola�s pivotal Phase III 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.
Comment: In February 2018 the CHMP issued a negative trend vote on the product's marketing application at its meeting. The committee said that additional steps would be needed to gain marketing approval in Europe.
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