FDA Approves COPD Medication

Breo Ellipta has been approved for long-term, once-daily maintenance treatment of airflow obstruction in patients.

The U.S. Food and Drug Administration has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough, and excessive phlegm. Smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third-leading cause of death in the United States.

Breo Ellipta decreases inflammation in the lungs and helps muscles around the airways of the lungs stay relaxed to increase airflow. "COPD is a serious disease that makes breathing difficult," said Dr. Curtis Rosebraugh, M.D., MPH, director of Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research. "The availability of new, long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."

According to FDA, Breo Ellipta's safety and efficacy were evaluated in 7,700 patients diagnosed with COPD. Its safety and efficacy in patients with asthma have not been established, and it is not approved for the treatment of asthma. It may cause serious side effects, including increased risks of pneumonia and bone fractures. The most common side effects reported by patients using Breo Ellipta include inflammation of the nasal passage, upper respiratory tract infection, headache, and oral candidiasis (thrush). Breo Ellipta was developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance.

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