European commission approves rivaroxaban for the treatment of pulmonary embolism and the prevention of recurrent deep vein thrombosis


Rivaroxaban (Xarelto, Bayer HealthCare) has been approved by the European Commission for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the European Union. 

Until now, the standard therapy has been the dual drug combination of daily injections of a low molecular weight heparin, together with an oral vitamin K antagonist (VKA). The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommended use or rivaroxaban for this indication on 18 October 2012.

“Today’s approval marks a turning point for both doctors and patients in the treatment and prevention of life-threatening blood clots in patients with pulmonary embolism. As a new treatment option, rivaroxaban offers a single-drug solution that works as fast as injectable enoxaparin and can provide protection for as long as needed,” said Harry R Büller, Academic Medical Center in Amsterdam, The Netherlands, who led the pivotal EINSTEIN clinical trial programme for rivaroxaban.

The new indication for rivaroxaban was based on clinical findings from the pivotal, global phase III EINSTEIN-PE study. With 4,833 patients enrolled, EINSTEIN-PE is the largest study ever conducted in the acute treatment of PE. The study compared the oral single-drug solution of rivaroxaban 15mg twice daily for three weeks, followed by 20mg once daily, with the current dual drug approach of subcutaneous enoxaparin followed by a VKA. Patients were treated for three, six or 12 months.

Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic DVT and non-fatal or fatal PE, without the need for laboratory monitoring. The overall bleeding rates were similar between the treatment groups, but importantly rivaroxaban was associated with significantly lower rates of major bleeding. The results from this study were published in the New England Journal of Medicine in April this year.

“A pulmonary embolism is a frightening experience for patients,” said Eve Knight, Co-Founder and CEO of the charity AntiCoagulation Europe (ACE). “The current standard of care can be complicated which adds to the stress and burden on the patient so today’s news is great for patients. With the approval of rivaroxaban for the treatment and prevention of PE, patients at last have the choice of a simple, fast and effective treatment option.”