Andexanet alfa - Portola Pharmaceuticals

Drug Profile

Andexanet alfa - Portola Pharmaceuticals

Alternative Names: AndexXa; AnXa; IndexXa; PRT-064445; PRT-4445; PRT-44545; Recombinant factor-Xa-Portola; rfXa-inhibitor-antidote

Latest Information Update: 24 Mar 2018

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At a glance

  • Originator Portola Pharmaceuticals
  • Class Antidotes; Antihaemorrhagics; Disulfides; Recombinant proteins
  • Mechanism of Action Blood coagulation stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haemorrhage
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Haemorrhage

Most Recent Events

  • 15 Mar 2018 Interim efficacy and adverse events data from a phase IIIb/IV ANNEXA-4 trial in Haemorrhage presented at the 67th Annual Scientific Session of the American College of Cardiology (ACC-2018)
  • 20 Feb 2018 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) communicates a positive trend vote on the Marketing Authorisation Application (MAA) for andexanet alfa
  • 22 Dec 2017 FDA extends PDUFA action date from 03/02/2018 to 04/05/2018 for andexanet alfa for Haemorrhage (IV, Injection)
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