GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) 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. Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult patients with uncontrolled asthma across 15 countries. Positive headline results were reported in May 2019.
Although asthma is understood to be an inflammatory condition, additional bronchodilation administered through multiple-inhalers, has been proven to have a beneficial effect on asthma symptoms and lung function. Single-inhaler triple therapy would introduce a new treatment paradigm for managing those adult patients who remain symptomatic on an ICS/LABA combination
Christopher Corsico, SVP Development, GSK said: “Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms. This filing is an important step towards giving asthma patients an additional treatment option. If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.”