The FDA approved rivaroxaban (Xarelto) to prevent venous thromboembolism (VTE) and related deaths for at-risk acutely ill medical patients not at high risk of bleeding, Janssen Monday.
The approval was for the hospitalization and through discharge to a total recommended duration of 31 to 39 days.
"Rather than facing daily injections with older anticoagulants, patients now have a new oral treatment option that will help prevent blood clots, both in the hospital and after hospital discharge," James List, MD, PhD, head of Janssen's cardiovascular and metabolism research and development, said in the company's statement.
Rivaroxaban isn't the first direct oral anticoagulant to snag this indication, however: betrixaban (Bevyxxa) got approval in 2017 for VTE prophylaxis in at-risk adults hospitalized for an acute medical illness.
Guidelines from the recommend heparins or fondaparinux (Arixtra) for acutely medically ill patients but no routine use after discharge. The recommends against using direct oral anticoagulants like rivaroxaban during hospitalization for nonsurgical patients or routine anticoagulation after discharge.
Rivaroxaban is already approved for treatment of deep vein thrombosis (DVT) or pulmonary embolism and to prevent recurrence in patients who have already completed 6 months of initial treatment for it. It's also approved for DVT prevention in hip or knee replacement surgery patients.
The new indication in primary prophylaxis in-hospital was based on the MARINER and MAGELLAN trials.
MARINER failed in its primary endpoint of lowering risk of symptomatic VTE and death due to VTE compared with placebo but did show a reduction in nonfatal symptomatic events, albeit at the cost of more bleeding.
showed that rivaroxaban was on par with enoxaparin (Lovenox) for combined asymptomatic, symptomatic, or fatal VTE at 10 days and superior to it by 35 days, although again with more bleeding.
A was able to reach a "favorable benefit-risk profile" for rivaroxaban by adding exclusion criteria for high bleeding risk: active gastroduodenal ulcer, recent bleeding, active cancer, history of severe bronchiectasis or pulmonary cavitation, or dual antiplatelet therapy at baseline.