The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol; GlaxoSmithKline) for the maintenance treatment of asthma in patients aged 18 years and older.
Trelegy Ellipta combines fluticasone furoate, an inhaled corticosteroid with umeclidinium, an anticholinergic and vilanterol, a long-acting β2-adrenergic agonist (LABA). The approval was based on data from the double-blind, active-controlled phase 3 CAPTAIN study that evaluated the efficacy and safety of Trelegy Ellipta in 2436 adults with inadequately controlled asthma despite treatment with an inhaled corticosteroid (ICS)/LABA. Patients were randomized to 1 of the following groups and treatment was administered once daily:
- Trelegy Ellipta 100/62.5/25mcg (n=406),
- Trelegy Ellipta 200/62.5/25mcg (n=408),
- Fluticasone furoate/umeclidinium/vilanterol 100/31.25/25mcg (n=405),
- Fluticasone furoate/umeclidinium/vilanterol 200/31.25/25mcg (n=404)
- Fluticasone furoate/vilanterol (FF/VI) 100/25mcg (n=407), or
- Fluticasone furoate/vilanterol200/25mcg (n=406).
The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1) at 24 weeks.
Results of the study showed a statistically significant 110mL improvement in trough FEV1 with Trelegy Ellipta 100/62.5/25mcg compared with FF/VI 100/25mcg (P <.001, 95% CI, 66-153mL). In addition, there was a statistically significant 92mL improvement in trough FEV1 with the Trelegy Ellipta 200/62.5/25mcg dose vs FF/VI 200/25mcg (P <.001, 95% CI, 49-135mL).
As for safety, the most common adverse reactions reported with Trelegy Ellipta in patients with asthma were pharyngitis/nasopharyngitis, upper respiratory tract infection (URTI)/viral URTI, bronchitis, respiratory tract infection (RTI)/viral RTI, sinusitis/acute sinusitis, urinary tract infections, rhinitis, influenza, headache, and back pain.
Trelegy Ellipta is also indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. The product is available as an inhaler containing 100mcg of fluticasone furoate, 62.5mcg of umeclidinium, and 25mcg of vilanterol per inhalation for both COPD and asthma management.
The product is also supplied as an inhaler containing 200mcg of fluticasone furoate, 62.5mcg of umeclidinium, and 25mcg of vilanterol per inhalation for patients with asthma. Disease severity, previous asthma therapy, current control of asthma symptoms and risk of future exacerbations should all be considered when choosing a starting dose.
For more information visit gsk.com.
- FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US. https://us.gsk.com/en-us/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/. Accessed September 10, 2020.
- Trelegy Ellipta [package insert]. Research Triangle Park, NC; GlaxoSmithKline; 2020.