Rivaroxaban Supplemental New Drug Application Submitted to FDA for VTE Prophylaxis
The sNDA is based on combined data from the Phase 3 MAGELLAN and MARINER trials.
Janssen announced the submission of a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) to the Food and Drug Administration (FDA) for the prevention of venous thromboembolism (VTE) in medically ill patients.
The sNDA submission was supported by Phase 3 data from the MAGELLAN and MARINER trials which assessed the use of rivaroxaban in preventing VTE in acute medically ill patients while hospitalized and immediately after discharge. In MAGELLAN, Xarelto was found to be noninferior to enoxaparin in short-term use (10±4 days) and superior in long-term use (35±4 days) vs short-term use of enoxaparin followed by placebo. However, major clinically relevant bleeding was found to be higher in the Xarelto group.
The MARINER study evaluated Xarelto for VTE and VTE-related death prevention in medically ill adults following hospital discharge. The data showed Xarelto did not decrease the composite endpoint of VTE and VTE-related death but was associated with a significant reduction in symptomatic VTE with consistent and favorable safety.
Xarelto, a factor Xa inhibitor, is currently indicated to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), for the reduction of the risk of recurrent DVT/PE, and for primary prevention of DVT, which may lead to PE, in patients who have just had hip or knee replacement. It is available as 2.5mg, 10mg, 15mg, and 20mg strength tablets.
For more information call (800) 526-7736 or visit Xarelto.com.