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An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

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Trial Profile

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2025

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At a glance

  • Drugs Garadacimab (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Sponsors CSL Behring

Most Recent Events

  • 26 Feb 2025 According to a CSL Behring media release, Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization to ANDEMBRY (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. The approval is based on efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study.
  • 20 Feb 2025 According to a CSL Behring media release, the company announced that it has received manufacturing and marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for ANDEMBRY (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens. The approval of ANDEMBRY is based on the efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study.
  • 13 Feb 2025 According to a CSL media release, European Commission (EC) has approved ANDEMBRY for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older,based on results from VANGUARD trial and its open-label extension study.

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