GlaxoSmithKline (GSK) and Innoviva have filed an application for their respiratory drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) in the US seeking its use for the treatment of asthma in adults.
Trelegy Ellipta, which is a once-daily, single-inhaler triple therapy, was approved by the US Food and Drug Administration (FDA) in late 2017 for the long-term, once-daily maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).
The drug’s supplemental new drug application (sNDA), which is seeking its approval for asthma is backed by data from the CAPTAIN phase 3 clinical study.
The late-stage trial featured 2,436 adult patients with uncontrolled asthma and was held across 15 countries.
The phase 3 trial met the primary endpoint by delivering a statistically significant 110mL improvement in lung function at 24 weeks of treatment for FF/UMEC/VI 100/62.5/25mcg compared with Relvar/Breo 100/25mcg. The trial also showed a statistically significant 92mL improvement in trough FEV1 for FF/UMEC/VI 200/62.5/25mcg compared to Relvar/Breo 200/25mcg.
Results from the CAPTAIN trial were released in May 2019.
According to GSK, although asthma is considered to be an inflammatory condition, additional bronchodilation given through multiple-inhalers, has been shown to have a beneficial effect on asthma symptoms and lung function.
The pharma company said that single-inhaler triple therapy will introduce a new treatment paradigm for managing the adult patients who continue to be symptomatic on an ICS/LABA combination.
GSK development SVP Christopher Corsico 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.”
Trelegy Ellipta is said to combine three molecules in a single inhaler. The molecules are fluticasone furoate, which is an inhaled corticosteroid, umeclidinium, which is a long-acting muscarinic antagonist, and a long-acting beta agonist called vilanterol.
The molecules combination is delivered using GSK’s Ellipta dry powder inhaler.
In September this year, GSK said that results from the REALITI-A study showed that its FDA-approved asthma drug Nucala (mepolizumab) demonstrated a significant reduction in exacerbations in patients with severe eosinophilic asthma.
Apart from exacerbations, use of oral corticosteroids was significantly reduced in patients after one year of treatment with Nucala when administered in a routine care setting, in comparison to the prior 12 months.