FDA Approves Breo Ellipta for Treatment of COPD
Respiratory disease is the third-leading cause of death in the United States
MONDAY, May 13 (HealthDay News) -- 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 U.S. Food and Drug Administration to treat COPD.
COPD is the third-leading cause of death in the United States behind heart disease and cancer. 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 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.