A chest X-ray demonstrating severe COPD. Credit: James Heilman, MD.

GlaxoSmithKline (GSK) and Innoviva have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the expanded indication of Trelegy Ellipta to treat patients with chronic obstructive pulmonary disease (COPD).

Trelegy Ellipta is the brand name for fluticasone furoate / umeclidinium / vilanterol (FF / UMEC / VI), which is co-developed by the two companies.

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The filing is for an expanded indication of the drug for the maintenance treatment of airflow obstruction and reduction of exacerbations in COPD patients.

If approved, the drug can be used to treat patients who are at risk of an exacerbation and require triple therapy.

FF/UMEC/VI is the first once-daily treatment that would provide a combination of three molecules in a single inhaler.

“We have moved swiftly to file this data with the FDA.”

It comprises inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, administered once daily in GSK’s Ellipta dry powder inhaler.

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The sNDA submission is based on the positive IMPACT study that demonstrated the superiority of FF / UMEC / VI to the dual combination therapies (FF / VI and UMEC / VI) on multiple endpoints, including exacerbation rates, lung function and health-related quality of life.

GSK research and development president Patrick Vallance said: “Data from GSK’s landmark IMPACT study provide important information on the efficacy and safety of these molecules combined in a single inhaler and the benefit they can bring to appropriate patients when delivered as a triple combination therapy.

“We have moved swiftly to file this data with the FDA.”

On 18 September, FF/UMEC/VI received approval in the US for the long-term, once-daily, maintenance treatment of COPD patients receiving Breo (FF/VI) and require additional bronchodilation or who are receiving Breo and Incruse (UMEC).