The expanded indication was granted based on data from the IMPACT trial, in which it showed superiority to FF/VI and UMEC/VI.
The US Food and Drug Administration has approved an expanded indication for fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy Ellipta, GSK), for the long-term, once-daily maintenance of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
The new indication includes patients with chronic bronchitis and/or emphysema. The GlaxoSmithKline therapy is also indicated for the treatment of exacerbations in patients with COPD, but its indication does not include relief of acute bronchospasm or for the treatment of asthma.
“Following the initial approval of Trelegy Ellipta in September, we have analyzed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with [COPD],” Hal Barron, MD, the chief scientific officer and president of Research and Development at GSK, said in a statement. “We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly. We will continue to analyze the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients.”
The approval is based on a supplemental New Drug Application (sNDA) supported by data from the landmark IMPACT study in which FF/UMEC/VI displayed superiority to the inhaled corticosteroid/long-acting beta2-adrenergic agonist, FF/VI (Relvar/Breo Ellipta, GSK), and the long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist, UMEC/VI (Anoro Ellipta, GSK), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health-related quality of life.
Patients that received the triple therapy relayed a rate of 0.91 moderate to severe exacerbations per year during treatment, compared to 1.07 per year for patients that received FF/VI, and 1.21 per year in patients that received UMEC/VI (P <.001).
The study results also revealed a significant reduction in the risk of on-treatment all-cause mortality for both inhaled corticosteroid containing arms compared to UMEC/VI. The GSK triple therapy's on-treatment all-cause mortality risk (1.20%) was a 42.1% reduction to that of the combination therapy (1.88%; P = .011).
The GSK product was originally approved by the FDA in the fall of 2017 for the long-term, once-daily, maintenance treatment of patients with COPD who receive fluticasone furoate and vilanterol (Breo, GSK) and require additional bronchodilation, or who are receiving UMEC. A type II variation to support an expanded label in Europe was submitted to the European Medicines Agency in February 2018 and is under review, according to GSK.
“Up to half of patients with COPD on maintenance therapy will have experienced at least one exacerbation in the past 12 months, so gaining an indication that reflects the role Trelegy Ellipta can play in reducing this risk is important,” Ted Witek, PhD, MBA, the senior vice president and chief scientific officer at Innoviva, said in a statement. “We welcome this regulatory update which will allow physicians to offer the benefits of once-daily single inhaler triple therapy to appropriate patients with COPD.”