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Albutrepenonacog alfa - CSL Behring

Drug Profile

Albutrepenonacog alfa - CSL Behring

Alternative Names: Albumin fusion protein - CSL Behring; CSL 640; CSL-654; Factor IX (Recombinant) - CSL; Idelvion; Recombinant coagulation factor IX - CSL Behring; Recombinant factor IX - CSL Behring; Recombinant factor IX fusion protein linked with human albumin; rFIX-FP - CSL Behring; rIX-FP

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator CSL Behring
  • Class Albumins; Antihaemorrhagics; Blood coagulation factors; Recombinant fusion 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 Yes

Highest Development Phases

  • Marketed Haemophilia B

Most Recent Events

  • 02 Jun 2021 CSL Behring completes a phase III trial for Haemophilia B in Australia, Austria, Bulgaria, Canada, Czech Republic, Italy, France, Germany, Japan, Israel, Malaysia, Philippines, South Africa, Spain and USA (IV) (NCT02053792)
  • 03 Jul 2020 The European Medicines Agency approves a 21-day dosing regimen for albutrepenonacog alfa for Haemophilia B
  • 28 Mar 2020 No recent reports of development identified for clinical-Phase-Unknown development in Haemophilia in Unknown (SC)
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