FDA Approves Anoro Ellipta
FDA Approves Anoro Ellipta to Treat Chronic Obstructive Pulmonary Disease
December 18, 2013 -- 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 chronic obstructive pulmonary disease (COPD).
COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death 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,” said 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 availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”
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. 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 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. Anoro Ellipta should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm).
The FDA approved Anoro Ellipta with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug.
Anoro Ellipta may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm), cardiovascular effects, increased pressure in the eyes (acute narrow-angle glaucoma), and worsening of urinary retention. The most common side effects reported by patients using Anoro Ellipta included sore throat (pharyngitis), sinus infection (sinusitis), lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.
Anoro Ellipta is manufactured by GlaxoSmithKline, Research Triangle Park, N.C.
Posted: December 2013
- FDA Advisory Committee to Review Anoro Ellipta NDA - September 10, 2013
- FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD - September 10, 2013
- Theravance Announces FDA Advisory Committee to Review Anoro Ellipta (UMEC/VI) for COPD - August 2, 2013
- GSK and Theravance Announce FDA Acceptance of New Drug Application Submission in the US for Anoro Ellipta for COPD - February 19, 2013