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.
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