Breo Ellipta Approved for COPD

Americans with chronic obstructive pulmonary disease (COPD) may have new help in their 

quest to breathe better, with the approval of Breo Ellipta.

This combination drug has been approved by the Food and Drug Administration to treat 

COPD, which includes chronic bronchitis or emphysema.

COPD is the third-leading cause of death in the U.S. behind heart disease and cancer, with 

typical symptoms including chronic cough, chest tightness and excess phlegm. Breo Ellipta 

(fluticasone furoate and vilanterol inhalation powder) is designed to reduce lung 

inflammation and to relax muscles that impact the lung airways.

The drug's safety and effectiveness were clinically evaluated in some 7,700 people with 

COPD. Common side effects included nasal inflammation, upper respiratory infection and 

headache.

Less common but more serious side effects could include bone fracture andpneumonia, 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.