Janssen Research & Development has launched EXPLORER, a comprehensive, global research program for XARELTO (rivaroxaban), an oral anticoagulant. The program includes studies that will evaluate XARELTO for investigational use in patients with chronic heart failure and in those with coronary artery disease or peripheral artery disease.
XARELTO does not require routine blood monitoring, and with approvals for six distinct uses it has a broad indication profile. XARELTO is approved in the U.S. for reducing the risk of strokes in patients with nonvalvular atrial fibrillation, as a treatment for deep vein thrombosis and pulmonary embolism and for reducing the risk of blood clots in the legs and lungs of people who have had hip or knee replacement surgery.
The extensive program of clinical trials evaluating XARELTO makes the compound the most studied oral, Factor Xa inhibitor. By the time of its completion, more than 100,000 patients will have participated in the XARELTO clinical development program.
"Janssen is dedicated to improving patient outcomes in the cardiovascular space and the EXPLORER program is one important way we are expressing our commitment to patients with unmet medical needs," said Troy Sarich, vice president and compound development team leader at Janssen R&D. "The EXPLORER program seeks to build upon the broad set of approved indications, and further assess potential benefits of XARELTO in additional patient populations who may benefit from oral anticoagulation treatment."
As part of the EXPLORER program, Janssen and its development partner, Bayer HealthCare, will enroll patients into five global clinical trials:
Janssen also recently announced a clinical collaboration agreement with Portola Pharmaceuticals and Bayer HealthCare to evaluate an investigational-stage antidote for Factor Xa inhibitors. This proof-of-concept study is scheduled to complete in the second half of 2013.
On March 4, 2012, Janssen said the FDA issued a second complete response letter regarding a supplemental New Drug Application for XARELTO for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome. Janssen is evaluating the letter and will respond to the agency's questions.