GSK's, Theravance's Anoro Ellipta receives FDA approval

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

"Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD," FDA Office of Drug Evaluation II director Curtis Rosebraugh said. "The availability of new, long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."

The drug is a long-acting beta2-adrenergic agonist, or LABA, which is designed to improve breathing by relaxing the muscles of the airways to allow more air to flow into the lungs. The drug carries a boxed warning, the strongest FDA-mandated warning a product can have, that LABAs increase the risk of asthma-related death; the drug is not approved as a treatment for asthma, the FDA said.