Andexanet alfa

Drug Profile

Andexanet alfa

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

Latest Information Update: 07 Aug 2017

$50 / €47 *
* $ price applies to USA, Canada and Latin America. € price applies to the rest of the world. Final gross prices may vary according to local VAT.

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 Aug 2017 FDA assigns PDUFA action date of 02/02/2018 for andexanet alfa for Haemorrhage (IV, Injection)
  • 03 Aug 2017 Portola Pharmaceuticals resubmits the Biologics License Application to the US FDA’s Center for Biologics Evaluation and Research for Haemorrhage
  • 22 Apr 2017 Pharmacodynamics data from a preclinical study in Haemorrhage presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017)
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