GSK and Theravance have announced that a study called SUMMIT (Study to Understand Mortality and MorbidITy in COPD ) showed that COPD patients treated with the Breo/Relvar Ellipta fluticasone furoate/vilanterol DPI had lower risk of dying than those treated with placebo, but the difference was not statistically significant. Almost 16,500 COPD patients who had either a history of cardiovascular disease or an increased risk took part in the study.
The fluticasone furoate/vilanterol DPI is marketed as Breo Ellipta in the US and as Relvar Ellipta in Europe. Breo Ellipta was approved by the FDA for the treatment of COPD in 2013 and for the treatment of asthma in April 2015. Relvar Ellipta was approved in Europe for the treatment of COPD in 2013.
For patients using Breo Ellipta, the incidence of serious cardiovascular adverse events was 8.5% compared to 7.7% for patients using a placebo. The risk of a cardiovascular event was 7.4% lower for patients using Breo Ellipta versus placebo, which was not statistically significant. The statistical significance of a number of other endpoints could not be determined because the primary endpoint (time to death from any cause) was not met, the companies said.
GSK Senior VP and Head, Global Respiratory Franchise Eric Dube commented, “SUMMIT is an important study as this is the first time that survival has been studied in this under-researched co-morbid patient population. While we didn’t achieve statistical significance on the primary endpoint, we believe the full data set will be beneficial and informative to the respiratory and cardiovascular scientific community. Relvar/Breo 100/25mcg continues to play an important role in the treatment of appropriate patients with COPD and as leaders in respiratory, GSK remains committed to tackling the major challenges that physicians and patients face in the treatment of respiratory disease.”
Theravance President and CEO Michael W. Aguiar added, “While we were unable to demonstrate a statistically significant survival benefit in this population, the full data set from SUMMIT, the largest study with Relvar/Breo conducted to date, provides additional confidence in the safety and efficacy of Relvar/Breo 100/25mcg as a once-a-day treatment to improve lung function and reduce exacerbation risk in patients with COPD.”
Read the GSK/Theravance press release.
