Recombinant factor IX - Baxalta

Drug Profile

Recombinant factor IX - Baxalta

Alternative Names: BAX 326; Coagulation Factor IX (Recombinant) - Baxalta; Nonacog gamma - Baxalta; rFIX; Rixubis

Latest Information Update: 19 Sep 2017

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At a glance

  • Originator Baxter International
  • Developer Baxter International; Shire
  • Class Antihaemorrhagics; Blood coagulation factors; Recombinant proteins
  • Mechanism of Action Blood coagulation factor replacements; Factor X stimulants
  • Orphan Drug Status

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

    Yes - Haemophilia B
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemophilia B

Most Recent Events

  • 29 Jun 2017 Baxter completes a phase III trial Haemophilia B (Treatment-experienced) in Argentina, Brazil, Bulgaria, Chile, Colombia, Czech Republic, Germany, India, Ireland, Italy, Japan, Poland, Romania, Russia, Spain, Sweden, Taiwan, Ukraine and United Kingdom (NCT01286779)
  • 15 Dec 2016 Biomarkers information updated
  • 30 Sep 2016 Launched for Haemophilia B in South Korea (IV) before September 2016
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