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FDA Approves New Treatment for VTE in Acutely Ill

Portola news release; 2017 Jun 23

Publish date:: June 28, 2017

The FDA has approved Bevyxxa (betrixaban) for hospital and extended duration prophylaxis of venous thromboembolism (VTE).

Indications: Bevyxxa is a factor Xa inhibitor indicated for the prophylaxis of VTE in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

Dosage and Administration: An initial single dose of 160 mg is recommended, followed by 80 mg once daily. Recommended duration of treatment is 35 to 42 days.

Efficacy and safety: Approval is based on results of a study showing that patients taking Bevyxxa experienced reduced incidence of deep vein thrombosis and pulmonary embolism blood clots compared with those taking enoxaparin plus placebo.

Side effects/risks: The most common adverse reaction is bleeding.

Citation:

US FDA approves Bevyxxa (betrixaban) first and only anticoagulant for hospital and extended duration prevention of venous thromboembolism (VTE) in acutely ill medical patients. [news release]. South San Francisco, CA: Portola Pharmaceuticals, Inc. June 23, 2017. http://investors.portola.com/mobile.view?c=198136&v=203&d=1&id=2282890. Accessed June 26, 2017.

Bevyxxa [package insert]. South San Francisco, CA: Portola Pharmaceuticals, Inc. 2017. http://bevyxxa.com/docs/Bevyxxa-Full-Prescribing-Information.pdf. Accessed June 26, 2017.

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