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: 03 Aug 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

  • 07 Aug 2018 Vertex Pharmaceuticals expects decision by EMA for MAA for line extension treatment of patients with Cystic fibrosis (In children, aged 2 - 5 years) in the first half of 2019
  • 31 Jul 2018 Vertex Pharmaceuticals plans a phase III trial for Cystic Fibrosis in July 2018 , (NCT03601637)
  • 27 Jun 2018 Phase-II clinical trials in Cystic fibrosis (In children) in Germany (PO) (EudraCT2017-003761-99)
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