Janssen expands global cardiovascular research program with three new studies
Janssen R&D is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO (rivaroxaban), a broadly indicated oral Factor Xa inhibitor. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medical illness. The new studies will include more than 11,000 patients in over 30 countries.
With the addition of these studies, the EXPLORER global cardiovascular research program now encompasses eight clinical trials assessing the safety and efficacy of rivaroxaban in high-risk patient populations, including those with chronic heart failure, coronary artery disease and peripheral artery disease. EXPLORER is an integral part of the extensive clinical development program for rivaroxaban, evaluating its use in a broad range of cardiovascular conditions.
"Each year in the U.S., more people die from DVT and PE than from motor vehicle accidents, breast cancer and HIV combined," said Anne Hermanowski Vosatka, M.D., Ph.D., FACC, vice president and compound development team leader for XARELTO at Janssen. "New trials added to the EXPLORER global cardiovascular research program will broaden our understanding of how rivaroxaban might help patients at risk for developing blood clots such as DVT or PE, addressing an urgent unmet need."
Specifically, Janssen and its development partner, Bayer HealthCare, will add the following new trials under the EXPLORER global cardiovascular research program:
- MARINER is a phase III study designed to evaluate the efficacy and safety of rivaroxaban once-daily compared with placebo to reduce the risk of symptomatic DVT and/or PE due to a concurrent medical illness for up to 45 days after hospital discharge. This study will include approximately 8,000 patients in more than 15 countries.
- EINSTEIN JUNIOR, including phase I, IIa, IIb and III clinical trials, will evaluate rivaroxaban according to an age- and body weight-adjusted dosing schedule for the treatment and secondary prevention of DVT and/or PE in pediatric populations. The study program will include at least 150 patients in 20 countries, and currently is enrolling participants for phase II trials. The phase III study is expected to start in September 2014.
- EINSTEIN CHOICE is a phase III study designed to evaluate whether once-daily rivaroxaban in doses of 10mg or 20mg is superior to aspirin for the prevention of symptomatic recurrent DVT and/or PE in patients who have completed between six and 12 months of anticoagulant therapy. The study will include approximately 2,850 patients in 31 countries and currently is enrolling participants.
In total, the global clinical development program for rivaroxaban will include 15 phase III clinical trials, 10 of which are completed. By the time of its completion in 2018, more than 136,000 patients are expected to have participated in the global clinical development program, including those patients assessed in EXPLORER.
In addition, Janssen and Bayer recently entered into an agreement with Portola Pharmaceuticals, to initiate phase III studies evaluating Portola's investigational Factor Xa inhibitor reversal agent, andexanet alpha, for use with XARELTO in emergency situations, such as for patients with major bleeding or those requiring emergency surgery. The clinical collaboration will be in effect through completion of phase III studies with XARELTO and any potential U.S. and E.U. regulatory approval of andexanet alfa. Phase III studies are expected to start in the first half of 2014.
DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and travels to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery. When PE occurs with large clots, multiple clots or when the patient already has pre-existing heart or lung disease, the event may be fatal. Each year up to 900,000 Americans experience a DVT or PE, resulting in up to 300,000 deaths.