GlaxoSmithKline and Innoviva's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) has bagged a new indication in the US with approval for use to treat asthma in patients aged 18 years.
The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the US, GSK noted.
The decision brings a new treatment option to around 30% of asthma patients who still experience symptoms despite being adherent to inhaled corticosteroids/long-acting beta agonist (ICS/LABA) combination therapy.
“Millions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms. [Trelegy's] approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once-a-day,” noted Dr Hal Barron, chief scientific officer and president R&D, GSK.
In the CAPTAIN study, published in The Lancet, a statistically significant improvement in lung function was observed in patients taking Trelegy Ellipta compared with the ICS/LABA, Relvar/Breo Ellipta.
The findings were also submitted to the EMA as part of the application to market the inhaler for asthma.