Umeclidinium (Incruse) for COPD Approved in Europe

Megan Brooks

Disclosures

April 28, 2014

The European Commission has approved the long-acting muscarinic antagonist umeclidinium (Incruse, GlaxoSmithKline) for maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD), the company said.

Umeclidinium 55 μg is given once daily, using the Ellipta dry powder inhaler.

As reported by Medscape Medical News, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of umeclidinium in February.

The committee's assessment of umeclidinium included a review of 7 phase 3 clinical trials involving more than 2500 patients with COPD who were treated with umeclidinium or placebo

The most common adverse events with umeclidinium reported in clinical trials were nasopharyngitis, upper respiratory tract infection, and headache (frequency of ≥1/100 to <1/10), the company said.

Consistent with its antimuscarinic activity, umeclidinium should be used with caution in patients with narrow-angle glaucoma or urinary retention.

"Umeclidinium should not be used in patients with asthma since it has not been studied in this patient population. Administration of umeclidinium may produce paradoxical bronchospasm that may be life-threatening. Umeclidinium should not be used for the treatment of acute episodes of bronchospasm. In the event of deterioration of COPD during treatment with umeclidinium, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken," the company advises.

Umeclidinium should also be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias. Atrial fibrillation and tachycardia may be seen after the administration of muscarinic receptor antagonists, including umeclidinium. Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical trials, the company says.

A new drug application for umeclidinium is currently under review at the US Food and Drug Administration. "The proposed umeclidinium dose of 62.5 μg is specified as the pre-dispensed dose (contained inside the inhaler) which is equivalent to the 55 μg delivered dose (emitted from the inhaler) authorized in Europe," the company notes.

Umeclidinium was approved for COPD in Canada earlier this month under the brand name Incruse Ellipta.

The company expects Incruse to be available in Europe in by the end of 2014.

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