Janssen Research & Development, LLC (Janssen) and its development partner, Bayer HealthCare, announced today the expansion of the EXPLORER global cardiovascular research program for XARELTO® (rivaroxaban) to include additional high-risk patient populations. New trials will investigate rivaroxaban, the most studied Factor Xa inhibitor, for the treatment of acute coronary syndrome (ACS), embolic stroke of undetermined source (ESUS) and peripheral artery disease (PAD). If this research is successful, Janssen may seek FDA approval of XARELTO® for these indications.
"Since March of 2013, through our ongoing partnership with Bayer, we have announced 11 new trials as part of our EXPLORER clinical trial program, with more indication-seeking trials underway than any other oral anticoagulant," said Anne Hermanowski Vosatka, M.D., Ph.D, FACC, Vice President and Compound Development Team Leader for XARELTO®, Janssen. "These new studies will help us to uncover the full potential of this medicine in making a difference for patients with critical medical needs."
The new trials initiated by Janssen and its development partner, Bayer HealthCare, are:
GEMINI 1 & 2 ACS, a global indication-seeking clinical program, designed to evaluate rivaroxaban in patients who suffer from acute coronary syndrome (ACS). The program will launch with GEMINI 1 ACS, to investigate the benefits of the dual pathway strategy of anticoagulation with rivaroxaban in combination with a single antiplatelet agent for long-term secondary prevention of additional cardiovascular events in patients with ACS. The study will include 2,000 to 3,000 patients in more than 10 countries. If successful, the Phase 2 study will be followed by GEMINI 2 ACS, a global Phase 3 study. The GEMINI ACS program builds off the global 19,000 patient ATLAS ACS 2-TIMI 51 trial, which showed treatment with XARELTO® resulted in reductions in important cardiovascular events.
ACS is a complication of coronary heart disease which is the leading cause of death in the United States. ACS is typically associated with the disruption of an atherosclerotic plaque and subsequent formation of a blood clot that can cause a sudden reduction in blood flow to the heart. Reduced blood flow to the heart can result in a heart attack or unstable angina, a condition signifying that a heart attack may soon occur. Each year more than 1.1 million Americans are discharged from the hospital with a primary or secondary diagnosis of ACS.
NAVIGATE ESUS, a global Phase 3 indication-seeking study, designed to evaluate rivaroxaban in patients with embolic stroke of undetermined source (ESUS). The study will include at least 7,000 patients in more than 25 countries.
Each year, more than 690,000 people in the United States are estimated to suffer an ischemic stroke, a condition where the blood flow to the brain is blocked by a clot. In approximately 25 percent of these patients, the embolic source causing the stroke is unknown, and there is limited knowledge available to guide treatment decisions for these patients.
VOYAGER PAD, a global Phase 3 indication-seeking study, designed to evaluate rivaroxaban in patients with peripheral artery disease (PAD) undergoing peripheral artery interventions. The study will include at least 5,000 patients in more than 20 countries.
PAD is estimated to affect more than eight million Americans age 40 and above, with prevalence increasing with age. PAD occurs when the build-up of plaque, or atherosclerosis, narrows or blocks vessels that transport blood from the heart to the limbs. Patients with PAD are at increased risk of heart attack and stroke.