The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with COPD, the third leading cause of death in the United States.
Anoro Ellipta is a combination of umeclidinium, an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs, according to the FDA.
The product is manufactured by GlaxoSmithKline, which recently launched another COPD pharmacological treatment, Breo Ellipta, in October 2013.
According to GSK, Anoro Ellipta is the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg.
“We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD. It is the first combination product approved in the US that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK, said Darrell Baker, SVP & Head, GSK Global Respiratory Franchise.
The safety and efficacy of Anoro Ellipta were evaluated in over 2,400 patients with a diagnosis of COPD. Those treated showed improved lung function compared to placebo, the FDA said.
“The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Anoro Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma, according to the FDA. Anoro Ellipta should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm).