Janssen submits FDA application for rivaroxaban to reduce secondary cardiovascular events in patients with acute coronary syndrome


On 29 December, Janssen Research & Development, announced that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking approval for the use of rivaroxaban (Xarelto) to reduce the risk of (thrombotic) cardiovascular events in patients with acute coronary syndrome.

The filing is supported by data from the pivotal phase III ATLAS ACS 2 TIMI 51 (Anti-Xa therapy to lower cardiovascular events in addition to aspirin with/without thienopyridine therapy in subjects with acute coronary syndrome) trial, which was presented in November at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine.

In the USA, rivaroxaban is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in people undergoing knee or hip replacement surgery, and for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. There are limited data on the relative effectiveness of rivaroxaban and warfarin in reducing the risk of stroke and systemic embolism in non-valvular atrial fibrillation patients when warfarin therapy is well-controlled.

Additionally, rivaroxaban is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. According to the company, by the time of its completion, more than 75,000 patients will have participated in the rivaroxaban clinical development programme. Rivaroxaban is being developed jointly by Jansen Research & Development and Bayer HealthCare. USA marketing rights for Xarelto are held by Janssen Pharmaceuticals.