FDA committee advises approval of Breo, a COPD drug

The U.S. Food and Drug Advisory Committee recommended approval of Breo Ellipta for the treatment of chronic obstructive pulmonary disease, officials say. GlaxoSmithKline and Theravance Inc. said the Pulmonary-Allergy Drugs Advisory Committee to the FDA voted the efficacy and safety data providedobstruction in patients with COPD -- 9 for, 4 against. "We are pleased with the outcome of today's meeting. COPD is a substantial evidence to support approval of Breo Ellipta as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives," Patrick Vallance, GSK's president of pharmaceuticals, research and development, said in a statement. "This positive recommendation is a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the United States. We look forward to a final decision from the FDA later this year."