Anoro Ellipta Approved for Chronic Obstructive Pulmonary Disease

New Drugs , News / October 3, 2016

The FDA approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for 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 may include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, and COPD is considered to be 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 airways and stops them from tightening, and vilanterol, a long-acting β2-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, whom showed improved lung function compared to placebo.

Anoro Ellipta 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 yet been established, and it is not approved for the treatment of asthma. The drug should also not be used as rescue therapy to treat sudden breathing problems (acute bronchospasm).

Serious side effects have been associated with Anoro Ellipta, 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.

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