The U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) regarding Bayer’s supplemental New Drug Application (NDA) for Xarelto (Rivaroxaban). The company said it is disappointed with the FDA decision.
Bayer applied for supplemental NDA for Xarelto 2.5 mg twice daily (BID) combined with standard antiplatelet therapy for the risk reduction of thrombotic cardiovascular events and stent thrombosis in patients with acute coronary syndrome (ACS). Thrombosis is the formation of a blood clot inside a blood vessel and can be life threatening in the form of venous arterial thromboembolism (VAT). VAT can lead to venous thromboembolism (VTE) and arterial thromboembolism, and requires active or preventive treatment to avoid potentially fatal medical outcomes.
Xarelto (rivaroxaban) is an oral anticoagulant currently approved for five indications across seven distinct areas of use. The drug is indicated in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors. Xarelto is also indicated in treatment of deep vein thrombosis and pulmonary embolism in adults, as well as its prevention.
The drug is also used to prevent VTE in adult patients undergoing elective knee replacement. Additionally, Xarelto is used to prevent atherothrombotic events after an ACS in adult patients with elevated cardiac biomarkers at a dose of 2.5 mg twice daily when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine (approved outside the US only). The European Commission gave approval for Xarelto in 2013 for the last indication.
Dr. Jörg Möller, member of the Bayer HealthCare Executive Committee and head of global development 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 U.S. with additional protection against stent thrombosis and life-threatening thrombotic cardiovascular events.”