WASHINGTON – GlaxoSmithKline plc says it has received U.S. approval to sell its once-a-day respiratory inhaler Breo Ellipta for a new use in asthma patients ages 18 and older.
The expanded approval from the Food and Drug Administration will help Glaxo replace sales of its bestselling product, Advair, which faces generic competition in Europe and pricing pressures in the U.S.
Breo Ellipta was originally approved to treat a form of lung disease. But Thursday’s approval expands the drug’s use to a much larger patient population of roughly 19 million U.S. adults who have asthma. The inhalable formulation combines two drug ingredients that help open the lung airways: a steroid and a beta agonist.
London-based Glaxo pays royalties on Breo Ellipta to the drug’s co-developer Theravance Inc., which is based in San Francisco.