FDA advisory committee votes against approval of rivaroxaban for acute coronary syndrome

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On 23 May, the FDA’s Cardiovascular and Renal Drugs advisory committee voted six to four, with one abstention, against the approval of the oral anticoagulant rivaroxaban (Xarelto, Bayer Healthcare/Jansen Pharmaceuticals) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome in combination with standard antiplatelet therapy (aspirin with or without clopidogrel). 

Data from the pivotal phase 3 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) supported rivaroxaban’s new indication. Results from the study showed that rivaroxaban given in combination with standard antiplatelet therapy were superior to standard therapy alone in preventing secondary cardiovascular events in patients with acute coronary syndrome. There were also low rates of major bleeding events in coronary artery bypass graft (CABG) surgery. Despite these results, the FDA’s panel voted against based on missing data on early patient withdrawals.

The FDA assigned a priority review designation to the supplemental new drug application filed on 29 December 2011 for rivaroxaban in patients with acute coronary syndrome. Recommendations from the advisory committee will be considered by the FDA in its review, but the FDA is not required to follow them.

Rivaroxaban is currently approved in the USA to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and to reduce the risk of both haemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

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