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Etranacogene dezaparvovec - CSL Behring

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Drug Profile

Etranacogene dezaparvovec - CSL Behring

Alternative Names: AAV5-FIX-Padua; AAV5-hFIXco-Padua; AMT 061; CSL-222; Etranacogene dezaparvovec - CSL Behring/uniQure; Etranacogene dezaparvovec-drlb; EtranaDez; HEMGENIX; Lanacogene vosiparvovec

Latest Information Update: 13 Feb 2025

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At a glance

  • Originator uniQure
  • Developer CSL Behring
  • Class Antihaemorrhagics; Gene therapies
  • Mechanism of Action Factor IX replacements; Gene transference
  • 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

  • 07 Feb 2025 Updated 4-years efficacy and adverse events data from the phase III HOPE-B trial in Haemophilia B released by CSL Behring
  • 16 Jul 2024 CSL Behring announces that the Canadian Agency for Drugs and Technologies in Health (CADTH) recommends public drug plan reimbursement for etranacogene dezaparvovec (HEMGENIX®) for the treatment of adults with hemophilia B
  • 15 Mar 2024 Registered for Haemophilia B in Australia (IV)

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