Breo Ellipta Approved for COPD
FRIDAY, May 10 -- Americans with chronic obstructive pulmonary disease (COPD) may have new help in their quest to breathe better, with the approval of Breo Ellipta on Friday.
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 FDA said Friday in a news release.
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 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.
The National Heart, Lung and Blood Institute has more about COPD.
Posted: May 2013