Complement C1 inhibitor protein - Shire plc

Drug Profile

Complement C1 inhibitor protein - Shire plc

Alternative Names: C1 Esterase Inhibitor (human); C1 INH-nf; C1-INH; Cetor; Cinryze; SHP-616

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Sanquin Blood Supply Foundation
  • Developer Sanquin Blood Supply Foundation; Shire; Shire ViroPharma; ViroPharma
  • Class Complement C1 inactivator proteins; Vascular disorder therapies
  • Mechanism of Action Complement C1 inhibitors
  • Orphan Drug Status

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

    Yes - Angioedema
  • 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.

    Transplant rejection
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hereditary angioedema
  • Phase III Transplant rejection
  • Phase I Neuromyelitis optica
  • Clinical Phase Unknown Autoimmune haemolytic anaemia
  • Preclinical Delayed graft function
  • No development reported Myocardial infarction
  • Discontinued Paroxysmal nocturnal haemoglobinuria

Most Recent Events

  • 15 Dec 2016 Preregistration for Hereditary angioedema (In children) in European Union (IV) before December 2016
  • 15 Dec 2016 Preregistration for Hereditary angioedema (In children, Prevention) in European Union (IV) before December 2016
  • 15 Dec 2016 Committee for Medicinal Products for Human Use (CHMP) of EMA adopts a positive opinion recommending approval of complement C1 inhibitor protein for extension to an existing indication of Hereditary angioedema
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