Bayer sNDA seeks to update blockbuster drug's prescribing information

German pharma major Bayer (BAYN: DE) and development partner, Janssen Research & Development, part of US healthcare giant Johnson & Johnson (NYSE: JNJ), have announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration to update the prescribing information for Xarelto (rivaroxaban).

The submission seeks to include a 10mg once-daily dose for reducing the risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy as an additional treatment option alongside the already approved Xarelto 20 mg once-daily dose.

This application is supported by data from the Phase III EINSTEIN CHOICE study, which showed that both 10mg and 20mg once-daily dosages of Xarelto significantly reduced the risk of recurrent VTE compared with aspirin 100mg once daily (acetylsalicylic acid, ASA) in patients who had previously completed six to 12 months of anticoagulation therapy for treatment of pulmonary embolism (PE) and/or symptomatic deep vein thrombosis.