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FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration approved Breo Ellipta for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma. Breo Ellipta was developed by GlaxoSmithKline (GSK) in collaboration with Theravance (THRX).