FDA Approves Combination Inhaler for COPD
The FDA has approved Breo Ellipta (fluticasone furoate and vilanterol trifenatate; GlaxoSmithKline and Theravance) inhalation powder for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
Breo Ellipta contains fluticasone furoate, a synthetic inhaled corticosteroid, and vilanterol trifenatate, a long-acting beta2-adrenergic agonist (LABA). The combination inhaler 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.
The approval of Breo Ellipta is based on data that evaluated 7,700 patients with a clinical diagnosis of COPD. Treatment groups showed improved lung function and reduced exacerbations compared to placebo. The FDA approved Breo Ellipta patient medication guide includes instructions for use and information about the potential risks of taking the drug.
Breo Ellipta dry powder inhaler is available in a 100mcg/25mcg strength. The product will be available during the third quarter of 2013.
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