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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
About Portola Pharmaceuticals, Inc.
This announcement contains forward-looking statements, including statements relating to Portola Pharmaceuticals’ expectations regarding the regulatory status of betrixaban. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Portola Pharmaceuticals cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to the regulatory status of betrixaban in Europe. Risks and uncertainties relating to Portola Pharmaceuticals and its business can be found in the “Risk Factors” section of Portola Pharmaceuticals’ Annual Report on Form 10-K for 2017, which was filed with the