NICE calls for more data on Xarelto; Bayer files for added indication

In preliminary recommendations published yesterday (January 9) the UK’s drugs watchdog the National Institute for Clinical Health and Excellence (NICE) is asking German drug major Bayer HealthCare (BAY: DE) for more information on its oral anticoagulant Xarelto (rivaroxaban) for the prevention of stroke and systemic embolism in people with atrial fibrillation.

Rivaroxaban is an orally administered drug that helps to prevent blood from clotting. It does this by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation. Rivaroxaban has a UK marketing authorization for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischemic attack, the NICE noted.

Commenting on NICE’s draft recommendation, Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The importance of effective antithrombotic therapy in people with atrial fibrillation who are at risk of developing potentially fatal blood clots cannot be overestimated. The most commonly used antithrombotic - warfarin - is associated with a number of problems, such as the need for frequent monitoring of the blood’s clotting, which can have an adverse effect on quality of life and make compliance difficult for some people. Rivaroxaban, like dabigatran, which NICE is also assessing, represents a significant potential benefit for people with AF because it doesn’t require regular monitoring and dose adjustments.”