Revefenacin - Mylan/Theravance Biopharma

Drug Profile

Revefenacin - Mylan/Theravance Biopharma

Alternative Names: GSK 1160724; TD-4208

Latest Information Update: 06 Mar 2018

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At a glance

  • Originator Theravance
  • Developer Theravance Biopharma
  • Class Antiasthmatics; Biphenyl compounds; Carbamates; Piperidines
  • Mechanism of Action Muscarinic receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Chronic obstructive pulmonary disease

Most Recent Events

  • 27 Feb 2018 Safety and efficacy data from a phase IIIb trial in Chronic obstructive pulmonary disease released by Theravance Biopharma
  • 29 Jan 2018 FDA assigns PDUFA action date of 13/11/2018 for revefenacine for Chronic obstructive pulmonary disease
  • 29 Jan 2018 US FDA accepts NDA for Revefenacine for Chronic obstructive pulmonary disease for review
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