Fluticasone furoate/Vilanterol - GlaxoSmithKline/Innoviva

Drug Profile

Fluticasone furoate/Vilanterol - GlaxoSmithKline/Innoviva

Alternative Names: '444/'698; 444/698; Breo Ellipta; FF/GW642444; FF/VI; Fluticasone furoate/GW642444; Fluticasone furoate/vilanterol trifenatate; GSK-2285997; GW642444/GW685698; GW642444M/GW685698X; GW685698/GW642444; GW685698X/GW642444M; Relovair; Relvar Ellipta; Revinty Ellipta

Latest Information Update: 04 May 2018

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At a glance

  • Originator GlaxoSmithKline; Theravance
  • Developer GlaxoSmithKline; Innoviva
  • Class Androstadienes; Anti-inflammatories; Antiallergics; Antiasthmatics; Chlorobenzenes; Ethers; Glucocorticoids; Small molecules
  • Mechanism of Action Beta 2 adrenergic receptor agonists; Glucocorticoid receptor agonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Asthma; Chronic obstructive pulmonary disease

Most Recent Events

  • 20 Apr 2018 GlaxoSmithKline initiates enrolment in a phase III trial for Asthma (In adolescents, In children) in Spain and Italy (EudraCT2016-004086-87)
  • 08 Mar 2018 The European Commission approves a Type II variation (label update) for the use of once-daily fluticasone furoate/vilanterol in Asthma (Treatment-experienced)
  • 26 Jan 2018 Committee for Medicinal Products for Human Use (CHMP) recommends label update of fluticasone furoate/vilanterol for use in patients whose asthma is adequately controlled on both an inhaled corticosteroid and long-acting beta2-agonist
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