FDA Approves First Once-daily Single Inhaler Triple Therapy for Both Asthma, COPD Treatment

September 16, 2020

Along with COPD, fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) is now approved for the treatment of asthma in patients aged ≥18 years.

The US Food and Drug Administration (FDA) has approved a new indication for fluticasone furoate/umeclidinium/vilanterol, or FF/UMEC/VI, (Trelegy Ellipta; GlaxoSmithKline) for the treatment of asthma.

In addition to its use in the treatment of chronic obstructive pulmonary disease (COPD), FF/UMEC/VI is now also approved for the treatment of asthma in patients aged ≥18 years, according to a January 9, 2020 GlaxoSmithKline press release.

This new indication makes FF/UMEC/VI the first single inhaler triple therapy to be FDA-approved for the maintenance treatment of both asthma and COPD. It is also the only therapy of its kind that is available for patients in a once-daily inhalation.

The FDA-approved strength for both asthma and COPD is FF/UMEC/VI 100/62.5/25 mcg and an additional strength, FF/UMEC/VI 200/62.5/25 mcg, is approved for asthma alone.

The approval was based on a supplemental New Drug Application that included data from the CAPTAIN study, which was a randomized, double-blind, active controlled, 6-arm parallel group, global multicenter study.

The CAPTAIN study evaluated FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) vs 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.

The results of the study found that in patients uncontrolled on ICS/LABA therapy, the additional bronchodilation provided by FF/UMEC/VI showed significant improvements in lung function vs FF/VI, in a single daily dose.

The GSK release notes that approximately 30% of adults treated for asthma still experience symptoms, despite adherence to ICS/LABA combination therapy.

“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. We welcome the news that for appropriate patients, Trelegy Ellipta will now be available as a new treatment option,” said Tonya Winders, president of the global, not-for-profit patient education and advocacy organization, Global Allergy and Airways Patient Platform, Vienna, Austria, in the same press release.