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: 25 Mar 2017

Price : $50

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
  • 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

  • Marketed Cystic fibrosis

Most Recent Events

  • 21 Dec 2016 Vertex Pharmaceuticals initiates a phase II trial in Cystic fibrosis (In adolescents, In adults) in the Netherlands (EudraCT2016-001585-29)
  • 19 Dec 2016 Launched for Cystic fibrosis (In adolescents, In adults) in Austria and France before December 2016 (PO)
  • 07 Nov 2016 Efficacy and adverse events data from a phase III trial in Cystic fibrosis (In children) released by Vertex Pharmaceuticals
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