Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta; GlaxoSmithKline) is indicated for the treatment of asthma in patients aged 18 years and older.
Officials with the FDA have approved a new indication for fluticasone furoate/umeclidinium/vilanterol, or FF/UMEC/VI, (Trelegy Ellipta; GlaxoSmithKline), according to a press release.
In addition to its use in chronic obstructive pulmonary disease (COPD), FF/UMEC/VI Is now also indicated for the treatment of asthma in adult patients. It is not indicated for relief of acute bronchospasm.
With this new indication, FF/UMEC/VI 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.
The FDA-approved strength for both COPD and asthma is 100/62.5/25 mcg, and the additional strength for asthma alone is 200/62.5/25 mcg.
The approval of this supplemental New Drug Application was based on data from the CAPTAIN study. The CAPTAIN study was a randomized, double-blind, active controlled, 6-arm parallel group, multicenter study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with inhaled corticosteroids/long-acting beta agonist (ICS/LABA) maintenance asthma medication.
Results of the study showed that, in patients uncontrolled on ICS/LABA combination therapy, the additional bronchodilation provided by FF/UMEC/VI demonstrated significant improvements in lung function compared with FF/VI, in a single daily dose in an easy-to-use inhaler.
“In the US, there are almost 20 million adults living with asthma and we know that many of those continue to live with and adapt their lives around ongoing symptoms, despite taking medication as prescribed by their physician,” Tonya Winders, president, Global Allergy and Airways Patient Platform, said in a statement. “We welcome the news that for appropriate patients, Trelegy Ellipta will now be available as a new treatment option.”
1. FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US. News release. GlaxoSmithKline; September 9, 2020. Accessed September 10, 2020. https://www.gsk.com/en-gb/media/press-releases/fda-approves-trelegy-ellipta-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-both-asthma-and-copd-in-the-us/