Shots:

• The approval is based on P-III MAGELLAN study assessing Xarelto in preventing VTE in patients with acute medical illnesses- at risk for thromboembolic complications who are not at high risk of bleeding and is supported by P-III MARINER study assessing Xarelto vs PBO to prevent VTE and VTE-related death following hospital discharge
• The P-III MAGELLAN study resulted in meeting its two 1EPs i.e- non-inferiority to enoxaparin in short-term use (10 ± 4 days) and superiority in long-term use (35 ± 4 days) compared to short-term use of enoxaparin followed by PBO
• Xarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC)- discovered by Bayer- being jointly developed with Janssen and is approved in the US for the continuum of VTE care- from prevention and treatment of initial VTE via extended prevention of recurrent VTE

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Ref: Bayer | Image: Janssen