GlaxoSmithKline (GSK) and Innoviva have announced GSK’s New Drug Application submission to the Food and Drug Administration (FDA) for the once-daily, closed triple combo therapy; fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25mcg), for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 

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The combination therapy includes an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta2-adrenergic agonist (vilanterol). The submission is based on data from the closed triple combination therapy development program, FULFIL, the results of which were presented earlier this year, and also from separate studies with FF, UMEC and VI either alone or in combination.

“If approved, FF/UMEC/VI as a once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients,” said Mike Aguiar, CEO of Innoviva.

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