Janssen Submits sNDA for Xarelto to Prevent VTE in Acute Medically Ill Patients

Janssen Pharmaceutical announced the submission of a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) to the U.S. Food and Drug Administration (FDA) for the prevention of venous thromboembolism (VTE), or blood clots, in medically ill patients. This application is based on combined data from the Phase 3 MAGELLAN and MARINER trials, which evaluated Xarelto for the prevention of VTE in these patients during their hospital stay and immediately following discharge.

Approximately eight million Americans are hospitalized each year for acute medical illnesses, which include serious yet common conditions like heart failure, stroke, respiratory insufficiency, infectious diseases and inflammatory diseases. Hospital-associated VTE is the leading cause of premature death and disability in this population, and the risk of VTE also extends to the outpatient setting. In fact, 67 percent of recently hospitalized patients who develop a VTE do so within one month of discharge. Guidelines currently recommend that people at risk of VTE receive anticoagulants in the hospital but advise against routine anticoagulant use beyond the hospital stay.

"Despite being at high risk of VTE for up to six weeks when leaving the hospital, less than four percent of patients with acute medical illnesses are prescribed anticoagulant therapy to prevent VTE after they leave the hospital," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development. "We hope to make Xarelto available for these patients to prevent a VTE for the time that they remain at risk, beginning with hospitalization through at-home recovery."

Xarelto already has five approved VTE indications, including the treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction of the risk of recurrent DVT and PE, and primary prevention of DVT, which may lead to PE, in people who have just had hip or knee replacement surgery. In October 2017, the FDA approved a new dose regimen of 10 mg Xarelto once-daily for reducing the continued risk for recurrent VTE after completion of at least six months of initial therapy.

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