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November 25, 2013
08:06 EDTPTLAPortola granted breakthrough therapy designation for andexanet alfa
Portola Pharmaceuticals announced that it has been granted breakthrough therapy designation by the U.S. Food and Drug Administration for andexanet alfa, its investigational Factor Xa inhibitor antidote. The FDA's breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Portola is pursuing an Accelerated Approval pathway for andexanet alfa, a first-in-class agent, and plans to initiate registration-enabling studies in 2014. By the year 2020, Portola estimates that the number of patients presenting to the hospital who could benefit from an antidote could approach 500,000 in the United States, Japan and the five largest European Union countries alone. The company has previously reported data from its ongoing Phase 2 proof-of-concept studies of andexanet alfa and the Factor Xa inhibitors Eliquis and XARELTO. Additional studies are ongoing with Lovenox, Lixiana and Portola's investigational oral Factor Xa inhibitor, betrixaban, which is being studied in a Phase 3 clinical trial and has the potential to be the first oral Factor Xa inhibitor approved for venous thromboembolism prevention in acute medically ill patients.
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April 14, 2014
08:12 EDTPTLAPortola announces publication of Phase 3 APEX study design, rationale
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