Burosumab - Kyowa Hakko Kirin Pharma/Ultragenyx Pharmaceutical

Drug Profile

Burosumab - Kyowa Hakko Kirin Pharma/Ultragenyx Pharmaceutical

Alternative Names: Anti-FGF23 monoclonal antibody; Anti-fibroblast growth factor 23 monoclonal antibody; burosumab-twza; Crysvita; KRN-23; UX 023

Latest Information Update: 13 Nov 2018

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At a glance

  • Originator Kyowa Hakko Kirin
  • Developer Kyowa Hakko Kirin; Ultragenyx Pharmaceutical
  • Class Monoclonal antibodies
  • Mechanism of Action Fibroblast growth factor 23 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - X-linked dominant hypophosphataemic rickets; Osteomalacia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed X-linked dominant hypophosphataemic rickets
  • Phase III Osteomalacia
  • Phase II Nevus

Most Recent Events

  • 05 Nov 2018 Preregistration for X-linked dominant hypophosphataemic rickets in Colombia and Brazil (SC) prior to November 2018
  • 05 Nov 2018 Ultragenyx expects approval of burosumab for X-linked dominant hypophosphataemic rickets in Brozil and Columbia (SC) in 2019
  • 05 Nov 2018 Updated efficacy and adverse events data from a phase II trial in Osteomalacia presented at the 40th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR-2018)
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