UK – NICE backs restricted use of Ondexxya

NHS cost regulators have backed funding for Alexion's Ondexxya (andexanet alfa) to reverse anticoagulation of the direct factor Xa (FXa) inhibitors apixaban or rivaroxaban in adults who experience a life-threatening or uncontrolled bleed in the gastrointestinal (GI) tract.

Until now, there has been no licensed therapy to reverse FXa-associated major bleeds when treated with apixaban or rivaroxaban, which are increasingly used for the prevention and treatment of thrombotic events, such as deep vein thrombosis and pulmonary embolism, or if a patient is at high risk of a stroke due to an irregular heart rate (atrial fibrillation).

FXa inhibitors stop the blood from clotting normally to help prevent unwanted clots from forming, but in doing so can also raise the risk of major and potentially life-threatening bleeds…