The approval means the once-a-day, single-inhaler therapy will enter the U.S. market under the brand name Trelegy Ellipta. The approval applies to COPD patients on a fixed dose of Breo Ellipta (fluticasone furoate/vilanterol) who need additional help with airflow obstruction. It also applies to patients on Incruse Ellipta (umeclidinium) and Breo Ellipta.
Regulators did not approve it for acute bronchospasm or asthma.
GSK and Innoviva are seeking regulatory approval for the triple combo in other countries, including European Union members, Australia, and Canada.
“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,” Mike Aguiar, CEO of Innoviva, said in a press release.
“Trelegy Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine,” he added.
Trelegy Ellipta combines the inhaled corticosteroid fluticasone furoate, the long-acting muscarinic antagonist (LAMA) umeclidinium, and the long-acting beta2-adrenergic agonist (LABA) vilanterol. A dose consists of 1oo micrograms of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems,” said Eric Dube, a GlaxoSmithKline senior vice president who is head of its Global Respiratory Franchise. “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.”
The latest results of a Phase 3 clinical added to evidence that the combo is effective. The IMPACT trial (NCT02164513) covered 10,355 COPD patients. It showed that Trelegy Ellipta reduced the annual rate of patients’ moderate-to-severe exacerbations by 15 percent, compared with GSK’s Relvar/Breo Ellipta, and by 25 percent, compared with Anoro Ellipta (umeclidinium/vilanterol).
In addition, Trelegy Ellipta significantly improved patients’ lung function and quality of life, and slowed the progression of their disease.
The triple combo’s safety profile during the trial was consistent with previous reports on the individual drugs and their combinations, researchers said. The most common adverse events were upper respiratory tract infection, worsened COPD, pneumonia, and headache.
“The results of the IMPACT study have been long awaited by the medical community,” Aguiar said in another press release. “We believe these data will significantly contribute to the body of evidence on the use of single-inhaler triple therapy, as well as the ongoing role of ICS/LABA [Anoro Ellipta] and LAMA/LABA [Breo Ellipta] treatments in appropriate patients with COPD.”
“We are delighted with the positive results achieved in the IMPACT study,” added Patrick Vallance, GSK’s president of research and development. “This is the first study to report a comparison of a single-inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single-inhaler triple therapy to reduce exacerbations.
“We hope these results will inform global guidelines and look forward to sharing the results with regulatory authorities,” he said. “We will continue to analyze the wealth of data generated to further the understanding of the treatment of COPD.”
Researchers plan to present the complete results of the IMPACT trial at scientific meetings and publish them in academic journals.