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A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

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Trial Profile

A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2024

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At a glance

  • Drugs Efanesoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms XTEND-Kids; XTEND-Kids pediatric
  • Sponsors Bioverativ
  • Most Recent Events

    • 19 Jun 2024 According to Sobi media release, the European Commission also endorsed the European Medicines Agency (EMA) recommendation supporting ALTUVOCTs retention of orphan drug designation, granting a 10-year market exclusivity period based on the results from the XTEND-1 and XTEND-Kids studies.
    • 17 Jun 2024 According to Sobi media release, data from this trial will be presented at ISTH 2024, the 32nd Congress of the International Society on Thrombosis and Haemostasis. This event, taking place from 22nd to 26th June.
    • 26 Apr 2024 According to Sobi media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of efanesoctocog alfa, for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. The recommendation from the CHMP is based on the results from the XTEND-1 and XTEND-Kids studies
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