FDA approves GSK's COPD product
The FDA announced yesterday 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 (COPD).
COPD affects the lungs causing breathing difficulties, primarily due to airflow obstruction and is usually caused by smoking.
"Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD. The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."
Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.
The product is a combination of long-acting beta agonist (LABA) vilanterol and long-acting muscarinic antagonist (LAMA) umeclidinium bromide and was developed in collaboration with Theravance.
Related news:
GSK's Anoro first LAMA/LABA approved for COPD in US (PM Live)
Reference links:
FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease (press release)
