Bayer HealthCare’s oral anticoagulant Xarelto® (rivaroxaban) has been approved by the European Commission (EC) 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 EU.
The total cost to the NHS (direct and indirect) of managing DVT and PE is estimated to be £640 million. In 2013, there are expected to be 52,600 cases of DVT and 43,000 cases of PE in the UK. “Each year over 25,000 people in England die from venous thromboembolism (VTE) contracted in hospital. Approximately 1 in 3 patients who suffer a pulmonary embolism die within 3 months and, concerningly, PE remains a leading cause of hospital death,” said Dr Ander Cohen, honorary consultant vascular physician, Department of Vascular Surgery, King’s College Hospital, London. “This new approval will bring the benefits of rivaroxaban to more patients, where the need for a fast, effective and convenient therapy against blood clots is essential for both acute and long-term treatment.”
Pulmonary embolism occurs when a blood clot in the deep veins of the leg or pelvis detaches and travels to the lung via the heart, where it can block one of the pulmonary arteries. Without fast treatment, the resulting loss of lung function can rapidly lead to death.
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.
Dr Luke Howard, a Consultant Chest Physician from the National Pulmonary Hypertension Service at Hammersmith Hospital said: “Rivaroxban represents a real change in the management of PE. With its other indications (for; stroke prevention in non-valvular atrial fibrillation, the treatment and prevention of deep venous thrombosis and prophylaxis of VTE in patients undergoing major orthopaedic surgery), rivaroxaban is likely to lead the way to more acceptable anticoagulation.”
“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.”
The approval of rivaroxaban for the treatment of PE and the prevention of recurrent DVT and PE in adults is based on the important 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 15 mg twice daily for three weeks, followed by 20 mg 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.