EMA reaffirms positive benefit-risk balance of rivaroxaban

 The European Medicines Agency (EMA) has reaffirmed the positive benefit-risk balance of rivaroxaban (Xarelto) for stroke prevention in patients with atrial fibrillation. The announcement follows an investigation by the Committee for Medicinal Products for Human Use (CHMP) into the malfunctioning of the INR device used in the ROCKET AF trial, in a bid to determine if this had any impact on the study results. The EMA concluded that a defect with the INR device used in the ROCKET study does not change its conclusions on the overall safety or benefit-risk balance of rivaroxaban. Additionally, Bayer and its development partner Janssen