WASHINGTON (AP) — 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 best-selling 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.