A panel of experts from the Food and Drug Administration (FDA) has voted to approve an experimental inhaler drug from Theravance and GlaxoSmithKline for the treatment of chronic lung disease.
The ailment, often referred to as smoker's cough, can lead to a number of breathing problems such as emphysema and chronic bronchitis. COPD is the third-leading cause of death in the U.S. Tobacco plays a key role in the disease, as do genetic factors, asthma, respiratory infections and air pollutants.
The vote came through via a majority of Food and Drug Administration panelists who said that the inhaler is both safe and effective.
"We are pleased with the outcome of today's meeting," GSK President of Pharmaceuticals, R&D Patrick Vallance said in a news release. "COPD is a debilitating and progressive disease."
The Food and Drug Administration should make a decision on the Breo Ellipta inhaler by May 12. It is not required to approve the group's request but often does. The Breo drug is a combination of two respiratory drugs designed to reduce swelling and aid with the opening of lung air passages. The Ellipta inhaler is meant to be used with the drug.
"This positive recommendation is a crucial first step toward making Breo Ellipta available for appropriate COPD patients across the U.S.," GlaxoSmithKline said in a statement.
GlaxoSmithKline, which is based in the U.K., developed the program over the course of ten years. In doing so, it worked with California-based biopharmaceutical company Theravance, Inc. Stock for Theravance gained a significant boost as a result of the news from the Food and Drug Administration.
