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An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Trial Profile

An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

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

    • 02 Oct 2020 According to a Kyowa Kirinthe media release, the company announced that the European Commission has approved burosumab for use in older adolescents and adults with the rare disease X-linked hypophosphataemia. Based on data from UX023-CL303 and UX023-CL304 studies.
    • 24 Jul 2020 According to a Kyowa Kirinthe media release, the CHMP recommends that this approval is expanded to include all adolescents with radiographic evidence of bone disease, regardless of growth status, as well as adults with XLH. The CHMP opinion will now be reviewed by the European Commission, with a final decision expected in September 2020.
    • 24 Jul 2020 According to a Kyowa Kirinthe media release, based on the data from UX023-CL303 and UX023-CL304 studie, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded approval of CRYSVITA (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphataemia (XLH).
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