FDA approves triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), as Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with COPD.-GSK + Innoviva.

GlaxoSmithKline plc and Innoviva, Inc. announced that the FDA has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma. Trelegy Ellipta is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK�s Ellipta dry powder inhaler. It is the first once-daily product approved in the US that combines three active molecules in a single inhaler for the maintenance treatment of appropriate patients with COPD. The FDA-approved strength is FF/UMEC/VI 100/62.5/25 mcg.

Comment: Triple therapies include Trimbow (beclometasone + formoterol + glycopyrrolate) from Chiesi which has a European approval and PT 010 ( budesonide + formoterol +glycoprronium) from AstraZeneca which is in Phase III studies.