Portola Pharmaceuticals said that it will present an abstract about results from its trial in Phase 3b/4 of its investigational Factor Xa reversal agent, andexanet alfa, during a late-breaking clinical trial session at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18), in March.
“Factor Xa inhibitor-related bleeding leading to hospital admission and death is increasing because the adoption of these agents is growing significantly, and there is currently no approved reversal agent for patients,” said Jack Lawrence, chief medical officer of Portola. He said the new analyses from the ANNEXA-4 trial will add to the understanding of the potential role of andexanet alfa as an antidote to reverse anticoagulation in Factor Xa-associated bleeding.
Portola is developing andexanet alfa as a universal antidote for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. Andexanet alfa is currently under review by the U.S. Food and Drug Administration (FDA), with an assigned action date of May 4, 2018, and by the European Medicines Agency (EMA), with an expected decision in the first half of 2018.
ACC also has accepted two poster presentations regarding the unmet medical need for anticoagulant prophylaxis of venous thromboembolism in acute medically ill patients.