BETHESDA, MD 18 December 2013—FDA today announced the approval of umeclidinium–vilanterol inhalation powder for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
The GlaxoSmithKline product will be marketed as Anoro Ellipta. The company expects to launch the product in the United States during the first quarter of 2014.
for the combination product describes umeclidinium as an long-acting, antimuscarinic agent that relaxes smooth muscles in the airways.
GlaxoSmithKline stated that the drug, in combination with the long-acting beta2-adrenergic agonist (LABA) vilanterol, is the first FDA-approved once-daily treatment for COPD that contains two long-acting bronchodilators in a single inhaler.
The combination product is not indicated for the treatment of acute bronchospasm or asthma. A boxed warning in the labeling states that patients with asthma who are treated with a LABA are at increased risk for death.
Anoro Ellipta contains lactose and is contraindicated in people who are severely allergic to milk products.
Each dose of Anoro Ellipta consists of 62.5 µg of umeclidinium and 25 µg of vilanterol delivered using a dry-powder inhaler.
Among clinical trial participants treated with Anoro Ellipta, the most frequently reported adverse events included sore throat, sinusitis, lower-respiratory-tract infection, gastrointestinal symptoms, muscle spasms, and pain in the extremities, neck, and chest, according to GlaxoSmithKline.
The company stated that "significant hypokalemia" and transient hyperglycemia may occur in some patients who use the combination product.
Serious adverse events that may occur during treatment with Anoro Ellipta include paradoxical bronchospasm, cardiovascular effects, acute narrow-angle glaucoma, and worsening of urinary retention, according to FDA.
The labeling for Anoro Ellipta includes an FDA-required Medication Guide to educate patients about potential risks associated with the product and instructions for its proper use.
The inhalers will be supplied in 30- and 7-dose packs in sealed plastic trays that should remain unopened and stored at controlled room temperature until use. Instructions for using the inhalers are included in the labeling.