The Food and Drug Administration has rejected the supplemental new drug applications seeking the use of Bayer and Janssen’s anti-clotting drug Xarelto (rivaroxaban) for prevention of heart attacks or strokes in patients with acute coronary syndrome (ACS).
FDA has issued complete response letters (CRLs) regarding supplemental new drug applications (sNDAs) for the use of Xarelto 2.5mg twice-daily (BID) in combination with standard antiplatelet therapy to reduce the risk of stent thrombosis in ACS patients.
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Both sNDAs are based on results from the 15,526-patient 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) clinical trial of Xarelto.
The FDA panel looking into the clinical data from the J&J trial concluded that the data was inconclusive, so does not justify approval for wider uses of Xarelto.
Rivaroxaban was discovered by Bayer HealthCare and is being jointly developed with Janssen Research & Development.
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Bayer HealthCare markets Xarelto outside the US and Janssen Pharmaceuticals (a Johnson & Johnson Company) markets the drug in the US.
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By GlobalDataXarelto is currently used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem.
Bayer HealthCare member of the executive committee and head of global development Jörg Möller said: "We are disappointed with the outcome of the review and together with our cooperation partner Janssen Research & Development, LLC remain committed to providing ACS patients in the US with additional protection against stent thrombosis and life-threatening thrombotic cardiovascular events."
In May 2013, Xarelto was approved by the European Commission for the prevention of atherothrombotic events after an ACS in adult patients with elevated cardiac biomarkers at a dose of 2.5mg twice-daily (BID) co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
The drug is approved for five indications across seven distinct areas of use, protecting patients across more venous and arterial thromboembolic (VAT) conditions compared to any other novel oral anticoagulant.
Janssen Research & Development vice-president of Clinical Development Paul Burton said: "We are evaluating the contents of the letters and will determine the appropriate next steps."
ACS is a complication of coronary heart disease, which occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart.
The disruption of blood flow can cause a heart attack or unstable angina, a condition signifying that a heart attack may soon occur.
In the US, an estimated 1.2 million patients are discharged from the hospital with a diagnosis of ACS each year.
Image: Rivaroxaban is the most broadly indicated novel oral anticoagulant. Photo: courtesy of freedigitalphotos.net.
