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|FDA Informs Portola Pharmaceuticals at Mid-Cycle Review for Betrixaban That It Has Not Identified Issues that Require an Advisory Committee Meeting|
“Based on the APEX data, we remain confident in the potential for betrixaban to be approved as the first anticoagulant for extended-duration VTE prophylaxis in high-risk acute medically ill patients,” said
About VTE in Acute Medically Ill Patients
In the G7 countries, an estimated 24 million acute medically ill patients are hospitalized each year and are at risk of VTE, either while in the hospital or following discharge. More than 1 million VTE events and 150,000 VTE-related deaths occur annually in acute medically ill patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. More than half of VTE events occur after the patient is discharged. However, no anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for in-hospital and extended-duration VTE prophylaxis in acute medically ill patients who are hospitalized.
In the EU, the European Medicines Agency’s
About Portola Pharmaceuticals, Inc.