J&J seeks additional approval for anti-clotting drug
RARITAN, N.J. — Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.
J&J division Janssen Research & Development announced the submission of a supplemental new drug application for Xarelto (rivaroxaban) to the FDA for the two conditions and for preventing recurrent venous thromboembolism.
The submission was based on three trials of the "EINSTEIN" program, which enrolled more than 9,400 patients around the globe. Xarelto, an anticoagulant, already is approved for reducing the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery, and to reduce the risk of stroke and other complications related to migrating blood clots in some patients with atrial fibrillation. J&J is developing the drug with Bayer HealthCare.