Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant.
Janssen said the drug is used to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent symptomatic venous thromboembolism (VTE).
The company supports the submissions with data from the global Einstein program, which included two Phase 3 studies that evaluated the safety and efficacy of rivaroxaban.
The safety and efficacy of rivaroxaban in the long-term prevention of recurrent symptomatic VTE were evaluated in the third Phase 3 study.
DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs, while PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and travels to the heart, partially or completely blocking a branch of the pulmonary artery.
The collective term for both DVT and PE is VTE, which is seen in an estimated 900,000 Americans every year, resulting in an estimated 300,000 annual deaths.
