A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)

Trial Profile

A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Burosumab (Primary)
  • Indications X-linked dominant hypophosphataemic rickets
  • Focus Adverse reactions; Pharmacodynamics; Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical
  • Most Recent Events

    • 10 Oct 2017 The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for review of burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia (XLH) and has granted Priority Review status. The Prescription Drug User Fee Act (PDUFA) action date for the BLA is April 17, 2018.
    • 11 Sep 2017 According to a an Ultragenyx Pharmaceutical , 64-week data from this trial presented at the American Society for Bone and Mineral Research (ASBMR) 2017 Annual Meeting.
    • 24 Aug 2017 According to a Kyowa Hakko Kirin media release, 64-week data from this trial will be presented at the American Society for Bone and Mineral Research (ASBMR) 2017 Annual Meeting.
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