Recombinant factor VIIa - Baxalta

Drug Profile

Recombinant factor VIIa - Baxalta

Alternative Names: BAX 817; rFVIIa - Baxalta; rFVIIa BI

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Baxter International
  • Developer Shire
  • Class Blood coagulation factors; Coagulants; Recombinant proteins; Serine endopeptidases
  • Mechanism of Action Factor VIIa stimulants
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Haemophilia A; Haemophilia B

Most Recent Events

  • 03 Jun 2016 Baxalta has been acquired and merged into Shire
  • 13 Mar 2015 Efficacy and adverse events data from a phase III trial in Haemophilia A and B released by Baxter
  • 30 Nov 2014 Baxter completes a phase III trial in Haemophilia A and Haemophilia B in USA, Japan, Taiwan, Belgium, Romania, Poland, Spain, Ukraine, Serbia and Russia (NCT01757405)
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