Trelegy Ellipta, a triple-combination LABA/ICS inhaled treatment for COPD, has been approved for an expanded indication by the FDA, according to GlaxoSmithKline and Innoviva Inc.
The new indication is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma.
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) can now be used by US physicians to treat a broader population of COPD patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
The approval is based on a supplemental New Drug Application (sNDA) supported by data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
“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,” said Hal Barron, Chief Scientific Officer and President of Research and Development, GSK.
Dr Ted Witek, Senior Vice President and Chief Scientific Officer at Innoviva added: “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.”
Trelegy Ellipta was originally approved for use in the US in September 2017 for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo and require additional bronchodilation or who are receiving Breo and Incruse (UMEC).
Full US Prescribing Information, including Patient Information is available here.