Janssen Submits XARELTO to US FDA

Janssen Research & Development announced earlier this week that they have submitted supplemental New Drug Applications (sNDAs) to the US FDA (Food and Drug Administration).

Janssen are pursuing approval from the FDA for the use of XARELTO (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

The submissions to the Food and Drug Administration are reinforced by data from the international EINSTEIN program, which contained three Phase 3 studies that assessed the safety and efficacy of XARELTO.  Altogether, these Phase 3 studies contained over 9,400 patients.

Deep vein thrombosis is a condition where blood clots form in one of the large, deep veins, usually in the legs.  Pulmonary embolism is a severe condition that most frequently occurs when some, or all, of a DVT dislodges and travels to the heart, where it can partly or entirely block a branch of the pulmonary artery.  When pulmonary embolism occurs with big clots, multiple clots, or when the patient already has pre-existing heart or lung disease, the result can be fatal.

The collective term for both DVT and PE is VTE, which occurs in a predicted 900,000 Americans each year, causing in an predicted 300,000 annual deaths.

XARELTO belongs to a collection of drugs called anticoagulants, and works by blocking the blood clotting Factor Xa, resulting in decreasing the tendency to form clots.  In the US, XARELTO has been indicated to lower the risk of blood clots in the legs and lungs of people who have recently had knee or hip replacement surgery, and to reduce the risk of stroke and other complications related to migrating blood clots in people with atrial fibrillation, which was caused by a heart valve problem.

There is currently limited evidence on how XARELTO compares to warfarin in decreasing the risk of stroke when the blood levels of warfarin are well-controlled.


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