GSK seeks expanded label for Trelegy Ellipta inhaler in EU

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not adequately treated by a inhaled corticosteroid combined with a long-acting beta-adrenergic agonist. GSK and Innoviva hope that data from its Impact trial will support the product’s use in a broader population of COPD patients who are at risk of exacerbation. Get the full story at our sister site, Drug Delivery Business News. The post GSK seeks expanded label for Trelegy Ellipta inhaler in EU appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat GlaxoSmithKline plc Innoviva Source Type: news