The U.S. Food and Drug Administration (FDA) has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), a long-term, once-daily maintenance treatment of airflow obstruction in patients COPD! Developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance, the treatment works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.
“COPD is a serious, debilitating disease that makes breathing difficult,” says John W. Walsh, president and co-founder, COPD Foundation. “The availability of a long-term maintenance medication provides an additional treatment option for the estimated 24 million Americans living with COPD. We congratulate GlaxoSmithKline for developing Breo Ellipta, and anticipate that this new therapy will positively impact patient adherence to treatment regimens — and improve quality of life.”
Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD.
Those treated showed improved lung function and reduced exacerbations compared to placebo.
“For a disease suspected of impacting over 20 million Americans, we have struggled for far too long with a limited number of therapeutic options,” says Dr. Byron Thomashow, Clinical Professor of Medicine at Columbia University/New York Presbyterian Hospital and Chair of the COPD Foundations’ Board of Directors. “The recommendation of approval of this new once-daily agent is a very positive step forward. This is a unique agent; the first once daily combined inhaled steroid/long-acting beta agonist. And it’s important to note that the FDA has approved it both for maintenance and for preventing exacerbations. This drug will give us another excellent option for improving the lives of those living with COPD.”
The FDA approved Breo Ellipta with a medication guide that includes information about the potential risks. Breo Ellipta should not be used as a rescue therapy to treat acute bronchospasm, and is not recommended for people younger than 18 years.
“COPD is the third leading cause of death in the US, and yet we’ve seen far too few therapeutic options. This new drug approval represents a significant step forward,” says Dr. David Mannino, COPD Foundation Board Member and Professor in the Department of Preventative Medicine and Environmental Health at the University of Kentucky College of Public Health.
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