FDA Mini-Sentinel Assessment Confirms Safety and Effectiveness of XARELTO® (rivaroxaban) and its Association with a Lower Risk of Ischemic Stroke vs. Warfarin

TITUSVILLE, N.J., Jan. 16, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced findings from the U.S. Food and Drug Administration's (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO^® (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm XARELTO^®'s safety and effectiveness across a wide range of patients. The FDA Mini-Sentinel report also notes a lower risk of ischemic stroke was associated with the use of XARELTO^® compared to warfarin and lasted throughout the more than three-year analysis.

The Sentinel Initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the safety of approved and FDA-regulated medical products using existing electronic healthcare data from multiple sources. The Initiative is FDA's response to the Food and Drug Administration Amendments Act (FDAAA), and includes the Mini- Sentinel, a working pilot project to develop an active surveillance system and complement existing methods of safety surveillance.

"We're pleased to see the Sentinel Initiative in action and that FDA's findings are consistent with results from other independent real-world and post-marketing studies," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen Pharmaceuticals, Inc. "These FDA results yet again confirm the positive benefit-risk profile of XARELTO^® across a wide range of patients."

This FDA analysis evaluated the safety of XARELTO^® in people with nonvalvular atrial fibrillation (AF) who initiated XARELTO^® or warfarin from November 2011 to April 2015. To examine the safety of both products, methodologies included assessing ICD-9-CM codes from inpatient claims and evaluating rates of gastrointestinal (GI) bleeding, ischemic stroke and intracranial hemorrhage in patients with AF.

In its report, FDA concludes this study, "demonstrates the capability of Sentinel to conduct prospective safety monitoring with sophisticated re-usable tools and does not raise any new safety concerns regarding use of rivaroxaban."

Nearly six million Americans are diagnosed with AF, an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. It is the most common serious heart rhythm abnormality in people over the age of 65. When a clot forms in the heart due to AF, it can travel to the brain and cause a stroke.