Trelegy Ellipta filed with EU for asthma.- GlaxoSmithKline + Innoviva

GlaxoSmithKline and Innoviva announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA). The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult asthma patients across 15 countries whose disease remained inadequately controlled despite treatment with a combination of an inhaled corticosteroid and a long-acting beta2-agonist (ICS/LABA). The study met its primary endpoint, demonstrating a statistically significant improvement in lung function compared with the ICS/LABA, Relvar/Breo Ellipta.Comment: Trelegy Ellipta was approved in the European Union in November 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) who are not adequately treated by an ICS/LABA combination, or a combination of LABA and long-acting muscarinic antagonist (LAMA). If approved this would be the first once-daily single inhaler triple therapy available for asthma and COPD.