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FDA Approves Anoro Ellipta (Umeclidinium/Vilanterol) to Treat COPD
The FDA has approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder, GlaxoSmithKline) 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 the disease. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the U.S.
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 more than 2,400 patients with COPD. Treated patients showed improved lung function compared with those given 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 the drug is not approved for the treatment of asthma. Anoro Ellipta should not be used as a rescue therapy to treat acute bronchospasm.
Source: FDA; December 18, 2013.