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news.Janssen Pharmaceuticals, a member of Janssen Pharmaceutical Companies of Johnson & Johnson, has received the US Food and Drug Administration (FDA) approval for XARELTO (rivaroxaban tablets).
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XARELTO, which belongs to a group of medicines called anticoagulants, works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.
XARELTO is used to prevent deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.
XARELTO is approved for use at a 10 mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery.
The FDA approval was based on the data from the XARELTO Phase 3 clinical development program which reflects in the approved label showing efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin, followed by placebo.
In these trials, rivaroxaban and enoxaparin demonstrated similar safety profiles including low rates of major bleeding.
Janssen Pharmaceuticals Internal Medicine Medical Affairs vice president Paul Chang said they are pleased to make XARELTO tablets available to physicians to help them better protect their patients from these highly preventable surgical complications.