FDA Approves J&J's Oral Anticoagulant

Johnson & Johnson subisidiary Janssen Pharmaceuticals has announced its FDA approval for Xarelto, a novel, once-daily, oral anticoagulant.

Johnson & Johnson subisidiary Janssen Pharmaceuticals has announced its FDA approval for Xarelto, a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.

Pivotal data from the Xarelto Phase III clinical development program reflected in the approved label showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin (Lovenox) 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.