Canada Clears Umeclidinium (Incruse) for COPD

Megan Brooks


April 18, 2014

Canada has become the first country to approve umeclidinium monotherapy (Incruse Ellipta, GlaxoSmithKline) for chronic obstructive pulmonary disease (COPD) in adults, the company announced April 17.

Incruse Ellipta contains 62.5 μg umeclidinium delivered with the company's Ellipta dry powder inhaler.

Used once daily, the drug is indicated for long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is not indicated for the relief of acute COPD exacerbation and should not be used in patients younger than 18 years, the company said.

Umeclidinium, a long-acting muscarinic antagonist, has been tested in 7 phase 3 clinical trials involving more than 2500 patients with COPD treated with umeclidinium or placebo. Some of the studies investigated umeclidinium monotherapy and umeclidinium in combination with the long-acting β2 agonist vilanterol. The US Food and Drug Administration approved the umeclidinium/vilanterol combination in December 2013 under the trade name Anoro Ellipta.

Adverse events with umeclidinium reported in clinical trials include nasopharyngitis, upper respiratory tract infection, cough, arthralgia, abdominal pain, contusion, myalgia, pharyngitis, tachycardia, toothache, and viral upper respiratory tract infection, the company said.

Umeclidinium should be used with caution in patients with narrow-angle glaucoma or urinary retention and in patients with severe cardiovascular disorders, particularly cardiac arrhythmias. In some cases, treatment may need to be discontinued, the company cautioned.

Umeclidinium should be discontinued if paradoxical bronchospasm occurs, and other therapy should be considered if necessary. Coadministration with other anticholinergics should be avoided.

The product monograph with complete safety information will be available on the manufacturer's Web site or can be obtained by calling 1-800-387-7374.

Umeclidinium (monotherapy) is not currently licensed outside Canada.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of umeclidinium for COPD in February 2014, as reported by Medscape Medical News. A new drug application for umeclidinium is currently under review at the US Food and Drug Administration.


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