The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s regulatory submission seeking an additional indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of asthma.
The application for the joint GSK and Innoviva drug, a once-daily, single-inhaler triple therapy, is supported by the pivotal Phase III clinical CAPTAIN study. The companies confirmed that in the study the therapy met its primary endpoint, demonstrating a statistically significant improvement in lung function compared with the ICS/LABA, Relvar/Breo Ellipta.
As it stands there is no single inhaled triple therapy available for the treatment of asthma in Europe, and at least 30% of asthma patients continue to experience symptoms even when adherent to ICS/LABA treatment.
In October last year GSK also filed for a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking the same indication extension.
The drug is already approved in the European Union since 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).
Recently, Novartis abandoned its asthma therapy - fevipiprant - after “disappointing” results in a late-stage trial, which showed the treatment did not meet its clinically relevant threshold for reduction in rate of moderate-to-severe exacerbation compared to placebo.