The Food and Drug Administration says it has approved a new once-a-day inhaler drug from GlaxoSmithKline for patients with chronic lung disease.
GSK (NYSE: GSK) and its partner Theravance Inc. won approval of their once-daily Breo Ellipta for a lung disorder that is the third-leading cause of death in the nation.
The FDA cleared the dry powder inhaler to treat exacerbations of chronic obstructive pulmonary disease and airflow obstruction, the agency said today in a statement.
The agency cleared the Breo Ellipta inhaler for long-term use and to control flare-ups in patients with chronic obstructive pulmonary disorder, often called smoker’s cough. The lung ailment can cause a number of breathing problems, including chronic bronchitis and emphysema.
Breo Ellipta delivers a combination of two drugs that reduce inflammation in the lungs and relax airways to ease breathing. The drug carries a warning that it is not approved for asthma.
GSK, a leader in respiratory medicine, already sells the asthma treatment Advair, its best-selling product with more than $4 billion in sales per year. The British drugmaker collaborated on the inhaler with South San Francisco-based Theravance on the new product.
GSK operates its North American headquarters in RTP.
