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Teprotumumab - Horizon Therapeutics plc

Drug Profile

Teprotumumab - Horizon Therapeutics plc

Alternative Names: HZN 001; Insulin-like-growth-factor-1-receptor-antagonist-antibody-River-Vision-Development; R 1507; RG 1507; RO-4858696; RV 001-River-Vision

Latest Information Update: 10 Nov 2019

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At a glance

  • Originator Genmab; Roche
  • Developer Horizon Therapeutics plc; Roche
  • Class Antineoplastics; Eye disorder therapies; Monoclonal antibodies
  • Mechanism of Action Insulin-like growth factor-I receptor antagonists
  • Orphan Drug Status

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

    Yes - Graves ophthalmopathy
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Graves ophthalmopathy
  • No development reported Diabetic macular oedema
  • Discontinued Advanced breast cancer; Hodgkin's disease; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Sarcoma; Solid tumours

Most Recent Events

  • 31 Oct 2019 Pooled safety and efficacy data from phase II and the phase III OPTIC trials in Graves ophthalmopathy released by Horizon Therapeutics
  • 13 Oct 2019 Efficacy and safety data from the phase III OPTIC trial in Graves ophthalmopathy released by Horizon Therapeutics
  • 09 Sep 2019 FDA assigns PDUFA action date of 08/03/2020 for teprotumumab for Graves ophthalmopathy
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