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Rivaroxaban recommended for EU approval
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The European Committee for Medicinal Products for Human Use has recommended rivaroxaban for the treatment of pulmonary embolism and the prevention of recurrent deep vein thrombosis and pulmonary embolism in adults. The decision on approval by the European Commission is expected before the end of the year.
According to a company press release, the recommendation by the European Committee for Medicinal Products for Human Use to approve the oral anticoagulant rivaroxaban (Xarelto, Bayer HealthCare) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults is based on the clinical findings from the EINSTEIN-PE study. More than 4,800 patients were treated for either 3 months, 6 months or 12 months, comparing rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily with the current dual drug approach of subcutaneous enoxaparin followed by a VKA.
Rivaroxaban reduced the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic DVT and non-fatal or fatal PE, and was comparable to that of the current standard therapy without the need for laboratory monitoring. Overall bleeding rates were similar between the treatment groups, however researchers found that rivaroxaban was associated with lower rates of major bleeding.