Ivacaftor/lumacaftor

Drug Profile

Ivacaftor/lumacaftor

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

Latest Information Update: 22 Sep 2017

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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

  • 01 Sep 2017 Vertex Pharmaceuticals Incorporated completes a phase III trial for Cystic fibrosis (In children) in USA and Canada (PO) (NCT02797132)
  • 13 Jul 2017 Launched for Cystic fibrosis (In adolescents, In adults) in Luxembourg, Italy, Ireland, Denmark (PO) before July 2017
  • 13 Jul 2017 Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA) agrees to reimburse Ivacaftor/lumacaftor for Cystic fibrosis (In adolescents, In adults) in Italy
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