|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
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