HealthDay News — Americans with chronic obstructive pulmonary disease (COPD) have new help in their quest to breathe better. The FDA has approved the once-daily inhaled drug Breo Ellipta to treat COPD, the third-leading cause of death in the United States behind heart disease and cancer.
The drug, a fluticasone furoate/vilanterol combination powder, is designed to reduce lung inflammation and to relax muscles that impact the lung airways, the FDA said in a news release. It is intended for long-term maintenance therapy in patients with COPD, including those with chronic bronchitis and emphysema, as well as to reduce exacerbations of COPD in patients with a history of exacerbations.
The approval comes after trials involving 7,700 people with COPD show Breo Ellipta is safe and effective. Results from two separate studies involving 206 and 204 patients indicate the medication improved mean FEV1 by 173 mL and 209 mL, respectively, compared with placebo.
Breo Ellipta also reduced moderate and severe exacerbations by 21% and 34%, but only the former was statistically significant, the FDA noted.
Common side effects included nasal inflammation, upper respiratory infection and headache. Less common but more serious side effects could include bone fracture and pneumonia, the agency said.
The drug’s label will carry a warning of increased risk for asthma-related death. The medication has not been tested in, or approved for, people with asthma, the FDA warned.
Breo Ellipta was developed by North Carolina-based GlaxoSmithKline and San Francisco-based Theravance.