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."