Breo Ellipta Approved for COPD
Latest Lungs News
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.
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.
-- Scott Roberts