KRN 23

Drug Profile

KRN 23

Alternative Names: Anti-FGF 23 monoclonal antibody; Anti-fibroblast growth factor 23 monoclonal antibody; KRN-23; UX 023

Latest Information Update: 06 Jan 2017

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration X-linked dominant hypophosphataemic rickets
  • Phase II Nevus; Osteomalacia

Most Recent Events

  • 05 Jan 2017 Preregistration for X-linked dominant hypophosphataemic rickets (In children, In adults, In infants) in European Union (SC)
  • 05 Jan 2017 European Medicines Agency accepts MAA for X-linked dominant hypophosphataemic rickets (In adults, In children, In infants) for review
  • 07 Nov 2016 Ultragenyx announces intention to submit BLA for X-linked hypophosphataemia to US FDA in H2 2017
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