Breo Ellipta Approved for COPD05/10/13
FRIDAY, May 10 (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 on
This combination drug has been approved by the Food and Drug
Administration to treat COPD, which includes chronic bronchitis or
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
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