GlaxoSmithKline Plc (GSK,GSK.L) and Theravance, Inc. (THRX) Friday said the U.S Food and Drug Administration, or FDA, has approved BREO ELLIPTA as an inhaled, once daily, long-term treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD.
COPD refers to two lung diseases, chronic bronchitis and emphysema, and is characterised by obstruction to airflow that interferes with normal breathing.
BREO ELLIPTA is also indicated to reduce the risk of exacerbations of COPD in patients with a history of exacerbations.
The data submitted to the FDA included data from a comprehensive programme of non-clinical studies, 52 clinical pharmacology studies, and 11 clinical studies in 7,851 patients with COPD.
BREO ELLIPTA is expected to hit the market during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million to GSK following FDA approval.
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