On Sept. 10, 2020, GlaxoSmithKline and Innoviva announced the U.S. Food and Drug Administration (FDA) had approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).

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. This announcement marks GSK’s sixth major medicine approval in 2020 across areas of significant unmet medical need including cancer, HIV, respiratory and chronic kidney disease.

Trelegy’s approval for the maintenance treatment of asthma in patients aged 18 years and older introduces a new paradigm for managing the approximately 30% of adult asthma patients who still experience symptoms despite being adherent to inhaled corticosteroids/ long-acting beta agonist (ICS/LABA) combination therapy.