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A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome

Trial Profile

A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome

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

Latest Information Update: 18 Jun 2020

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At a glance

  • Drugs Burosumab (Primary)
  • Indications Nevus; Osteomalacia
  • Focus Therapeutic Use
  • Sponsors Kyowa Kirin
  • Most Recent Events

    • 18 Jun 2020 Results presented in a Food and Drug Administration Media Release.
    • 18 Jun 2020 According to a Ultragenyx Pharmaceutical media release, based on the data of UX023T-CL201 and KRN23-002 studies, the U.S. Food and Drug Administration (FDA) has approved Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older.
    • 13 Jan 2020 According to a Ultragenyx Pharmaceutical media release, company has submitted the sBLA to the U.S. FDA on December 18, 2019 and expects to hear back from FDA on submission acceptance and review designation in February 2020.
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