Ivacaftor/tezacaftor - Vertex Pharmaceuticals

Drug Profile

Ivacaftor/tezacaftor - Vertex Pharmaceuticals

Alternative Names: Ivacaftor/VX 661; TEZ/IVA; Tezacaftor/ivacaftor; VX-661/ivacaftor; VX-661/VX-770; VX-770/VX-661

Latest Information Update: 13 Sep 2017

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At a glance

  • Originator Cystic Fibrosis Foundation Therapeutics; Vertex Pharmaceuticals
  • Class Amides; Aminophenols; Cyclopropanes; Fluorobenzenes; 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 No

Highest Development Phases

  • Preregistration Cystic fibrosis

Most Recent Events

  • 28 Aug 2017 US FDA and EMA accepts NDA and MAA respectively for ivacaftor/tezacaftor for Cystic fibrosis for review
  • 24 Aug 2017 FDA assigns PDUFA action date of 28/02/2018 for ivacaftor/tezacaftor for Cystic fibrosis
  • 24 Aug 2017 Ivacaftor/tezacaftor receives priority review status for Cystic fibrosis in USA
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