Xarelto gets new UK indication

 The European Commission has granted approval for two new indications in the UK for Bayer HealthCare’s Xarelto (rivaroxaban).

The oral anticoagulant has been approved for the prevention of stroke and non-CNS systemic embolism in adults with non-valvular atrial fibrillation (AF) and one or more risk factors for stroke and for the treatment of deep vein thrombosis (DVT).

AF, the most common sustained cardiac rhythm disorder, affects around 750,000 people in the UK. In England each year, more than 25,000 people die from DVT contracted in hospital.

Xarelto is already indicated in the UK to help prevent VTE in patients undergoing elective total hip or knee replacement surgery. It’s believed to have been used in more than 100,000 patients in the UK and has treated more than a million patients worldwide for this indication.

The latest indication for the prevention of stroke and non-CNS systemic embolism was based on the results from ROCKET AF trial which demonstrated consistent findings.

NICE Guidelines recommend oral anticoagulants for the majority of AF patients to prevent stroke. However, current treatment options, such as warfarin, have limitations that challenge both healthcare professionals and patients. It is subject to potential limitations including unpredictable anticoagulant effects and can interact with numerous drugs and a wide array of food and drink in certain patients.

Xarelto is the first in a class of non-VKA anticoagulants called Factor Xa inhibitors. It offers a convenient oral dosing and a lower risk of interactions with other drugs compared with VKA antagonists, such as warfarin.

“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,” said Professor Keith Fox, Professor of Cardiology at the University of Edinburgh.