The US FDA has approved Trelegy Ellipta, a once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for the long-term, once-daily, maintenance treatment of patients with COPD, according to a press announcement from GlaxoSmithKline and Innoviva Inc.
The therapy is approved for COPD patients who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma, GSK and Innoviva noted.
Trelegy Ellipta is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler.
It is the first once-daily product approved in the US that combines three active molecules in a single inhaler for the maintenance treatment of appropriate patients with COPD. The FDA-approved strength is FF/UMEC/VI 100/62.5/25 mcg.
“COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems. The approval of Trelegy Ellipta, and the addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK that builds on our long heritage in this area,” said Eric Dube, SVP & Head, GSK Global Respiratory Franchise.
Mike Aguiar, CEO of Innoviva Inc, added, “This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta. Trelegy Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”
GSK and Innoviva believe Trelegy Ellipta will be available for use in the US shortly. Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the European Union, Australia and Canada.