Rivaroxaban approved in the UK for two new indications

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Rivaroxaban (Xarelto, Bayer Healthcare) has been approved by the European Commission for use in the United Kingdom across two new indications: the prevention of non-valvular AF-related stroke and systemic embolism and treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism following an acute DVT in adults.

For the prevention of stroke and non-central nervous systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors for stroke including congestive heart failure, hypertension, age over 75 years, diabetes and prior stroke, a fixed dose of 20mg once-daily has been recommended. A 15mg dose has been approved for moderate to severe renal impairment patients, based on subgroup results from the ROCKET AF trial that demonstrated consistent findings with overall ROCKET AF results.


Xarelto will be made available at a retail list price of £2.10 per tablet across both indications. This provides the NHS with an effective and simple to use non Vitamin K antagonist (VKA) oral anticoagulant in the UK.


“The consequences of blood clots can be overwhelming and their prevention and treatment should rightly be considered a health priority,” said Trudie Lobban, chief executive and founder of Atrial Fibrillation Association. “Thrombosis represents a massive burden on patients and the UK health system. Vitamin K antagonist eligible AF patients, especially those with a higher risk profile and with significant co-morbidities, tend to require more frequent INR testing. The additional tests have a significant impact on these patients’ quality of life as well as on NHS resources, so the approval of new therapy alternatives that are easier to manage than traditional treatments are welcome.”


Currently available treatments for the prevention of stroke in patients with AF include vitamin K antagonists such as warfarin. Warfarin is a highly effective stroke prevention therapy, but is subject to potential limitations including unpredictable anticoagulant effects in some patients which can cause difficulties in maintaining an appropriate therapeutic range, as well as a requirement for frequent routine coagulation monitoring. Additionally, for some patients warfarin can interact with numerous drugs and a wide array of food and drink.


The current standard of care in the treatment of DVT is the dual-drug approach of Low Molecular Weight Heparin (LMWH) initiated with a vitamin K antagonist. LMWH require administration by subcutaneous injection, which, although effective, can cause inconvenience, bruising and discomfort. Oral rivaroxaban provides a unique single drug solution and demonstrated comparable efficacy to the dual drug approach.


“Antithrombotic medicine is a fast-evolving area in which we are continually improving our understanding of how to combat blood clots,” said Keith Fox, professor of Cardiology at the University of Edinburgh, UK. “Treatments which act at a key point in the blood-clotting process are now emerging as an important therapy option in both short and long-term clinical settings, and have the potential to help re-shape clinical practice.”


Rivaroxaban is already available in the UK to help prevent venous thromboembolism in patients undergoing elective total hip or knee replacement surgery.