The FDA has approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with COPD.
The FDA announced today that is has approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.
The newly approved medication is a combination of umeclidinium (which is “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 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 announcement, 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 medication label will include language warning that long-acting beta2-adrenergic agonists increase the risk of asthma-related death.
The FDA also noted that because this medication has not been shown in clinical trials to be safe and effective in patients with asthma, it is not approved for the treatment of asthma and should not be used as a rescue therapy to treat acute bronchospasm.
Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in the news release that this medication “works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD.” He also noted that the availability of a new long-term maintenance medication “provides additional treatment options for the millions of Americans who suffer with COPD.”
In a news release announcing the approval, GlaxoSmithKline and Theravance, Inc. said that Anoro Ellipta (umeclidinium and vilanterol inhalation powder) 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.”
GSK and Theravance anticipate that launch activities in the US will commence during the first quarter of 2014.