Ivacaftor/lumacaftor - Vertex Pharmaceuticals

Drug Profile

Ivacaftor/lumacaftor - Vertex Pharmaceuticals

Alternative Names: Ivacaftor/VX-809; Lumacaftor/ivacaftor; Orkambi; VX-770/VX-809; VX-809/ivacaftor; VX-809/VX-770

Latest Information Update: 15 Jan 2018

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At a glance

  • Originator Cystic Fibrosis Foundation Therapeutics; Vertex Pharmaceuticals
  • Developer Vertex Pharmaceuticals
  • Class Amides; Aminophenols; Benzodioxoles; Benzoic acids; Cyclopropanes; Pyridines; Quinolones; Small molecules
  • Mechanism of Action Cystic fibrosis transmembrane conductance regulator stimulants
  • Orphan Drug Status

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

    Yes - Cystic fibrosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cystic fibrosis

Most Recent Events

  • 10 Jan 2018 European Commission approves extension of the marketing authorisation for ivacaftor/lumafactor to include children with Cystic fibrosis aged 6 to 11 years who have two copies of the F508del mutation
  • 10 Nov 2017 The Committee for Medicinal Products for Human Use recommends approval of ivacaftor/lumacaftor for Cystic fibrosis (In children) in European Union
  • 03 Nov 2017 Safety data from a phase III trial in Cystic fibrosis released by Vertex Pharmaceuticals
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