Glaxo files European marketing application for expanded use of Trelegy Ellipta [Seeking Alpha]
GSK plc American Depositary Shares (Each representing two Ordinary Shares) (GSK)
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Source: Seeking Alpha
Glaxo files European marketing application for expanded use of Trelegy ElliptaGlaxoSmithKline (NYSE:GSK) has submitted atype II variation to the European Medicines Agency (EMA) seeking approval for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) (FF/UMEC/VI) for the maintenance treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD).The data supporting the filing was generated in the Phase 3 IMPACT study that showed FF/UMEC/VI to be superior to inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo (FF/VI) and long-acting muscarinic antagonist/LABA, Anoro (UMEC/VI) on a range of endpoints.Trelegy Ellipta was approved in the EU in November 2017 for the maintenance treatment of adult patients with COPD who are not adequately treated by a combination of an ICS and a LABA.Click to subscribe to real-time analytics on GSKNow read:Understanding GlaxoSmithKline's Trelegy Ellipta »
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