GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval.
Now, the companies are touting results from a late-stage trial of Trelegy Ellipta, which is composed of an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta agonist.
The Impact trial, which enrolled 10,355 patients, met its primary endpoint. The study demonstrated statistically significant reductions in the annual rate of on-treatment moderate to severe exacerbations when compared with two, once-daily dual COPD therapies from GSK’s existing portfolio.
The safety profile of Trelegy Ellipta was consistent with the known profile of the individual medicines and their combinations, the companies reported. The most common adverse events were viral upper respiratory tract infection, worsening of COPD, pneumonia and headache.
“We are delighted with the positive results achieved in the Impact study. 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,” GSK’s president of R&D Patrick Vallance said in prepared remarks.
“It is important to note that all treatments were comprised of different combinations of the same component molecules administered in the same Ellipta inhaler, in a single dose, once a day to allow direct treatment comparisons. We hope these results will inform global guidelines and look forward to sharing the results with regulatory authorities. We will continue to analyse the wealth of data generated to further the understanding of the treatment of COPD.”
“The results of the Impact study have been long awaited by the medical community,” Innoviva CEO Mike Aguiar added. “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 and LAMA/LABA treatments in appropriate patients with COPD.”