GSK Lung Drug Fails to Meet Primary Goal in Clinical Trial
GlaxoSmithKline’s Breo Ellipta failed to meet its primary goal in a pivotal clinical trial of curbing death risk in patients suffering from chronic pulmonary obstructive disease.
The British pharmaceutical giant said last week that the risk of death was 12.2 percent lower among patients receiving the treatment versus placebo, but the results were not statistically significant to prove its ability in extending life.
The study began in 2011 and tracked 16,485 people from 43 countries who had chronic obstructive pulmonary disease, and either a comorbidity or risk of cardiovascular disease. Cardiovascular disease has been shown to double mortality in COPD patients.
Other promising targets — reduced rate of lung function decline and a degree of improvement for health-related quality of life — were not significant since the main study objective was not met.
Moreover, 23.2 percent of patients on the once-a-day powder inhaler experienced serious negative events such as myocardial infarction, stroke and pneumonia — 1 percent higher than patients on the placebo.
GSK had hoped that a strong positive result would stimulate sales of the drug, as its respiratory portfolio faces increasing competition. — Victoria Pelham