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European CHMP Maintains Negative Opinion on Portola Pharmaceuticals’ Betrixaban Following Appeal
The CHMP’s position is that betrixaban addresses an unmet medical need and showed a clinically relevant rate of prevention of thrombotic events in patients treated with betrixaban compared to those treated with enoxaparin. However, the committee did not consider the overall risk-benefit profile sufficiently robust when considering non-major bleeding in addition to major bleeding. Portola will continue working with regulatory authorities in countries outside the European Union to potentially bring this important new treatment option to patients as quickly as possible.
“We are disappointed by the Committee’s assessment given both the unmet need and the clinically meaningful outcomes of the APEX trial in reducing VTE and VTE-related deaths in a vulnerable patient population,” 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
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s two FDA-approved medicines are Bevyxxa® (betrixaban), the first and only oral, once-daily Factor Xa inhibitor for the prevention of VTE in adult patients hospitalized for an acute medical illness, and Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote for the Factor Xa inhibitors rivaroxaban and apixaban. The company also is advancing cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers.
This announcement contains forward-looking statements, including statements relating to
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