Portola Pharmaceuticals, Inc.® announced that the U.S. Food and Drug Administration (FDA) accepted Portola’s New Drug Application (NDA) granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
A priority review shortens the FDA review timeline to six months from the standard review period of 10 months. The application for betrixaban, an FDA-designated Fast Track investigational drug, was deemed sufficiently complete to permit a substantive review and has been given a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017.
Additionally, Portola announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for betrixaban for extended-duration prophylaxis of VTE in adults with acute medical illness and risk factors for VTE. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is reviewing the application under a standard 210-day review period.
“With the filing of our betrixaban NDA and MAA validation, we now look forward to working with the FDA and EMA with the potential for betrixaban to be the first anticoagulant approved for in-hospital and extended-duration VTE prophylaxis in high-risk acute medically ill patients,” said Bill Lis, chief executive officer of Portola.
The NDA and MAA for betrixaban are supported by data from Portola’s pivotal Phase 3 APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide and assessed the superiority of extended-duration anticoagulation with oral betrixaban for 35-42 days compared with standard-duration injectable enoxaparin for 10+4 days in preventing VTE in high-risk acute medically ill patients.
Full results from the multicenter, randomized, active-controlled APEX Study were presented at the 62nd Annual International Society on Thrombosis and Haemostasis (ISTH) Scientific and Standardization Committee (SSC) Meeting in May 2016 and published online in The New England Journal of Medicine in May 2016.
Results from three sub-studies of the APEX Study, including a retrospective sub-study that assessed the potential of extended-duration thromboprophylaxis with betrixaban to reduce the risk of stroke in hospitalized acute medically ill patients, were presented at the American Heart Association (AHA) Scientific Sessions in November 2016 and published in Circulation.