FDA OKs Umeclidinium (Incruse Ellipta) for COPD

Larry Hand


April 30, 2014

The US Food and Drug Administration (FDA) has approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) as a once-daily maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, according to the company.

The FDA approved a dose of 62.5 μg of the anticholinergic to be delivered through the company's Ellipta inhaler.

The approval follows the Canadian clearance for the drug in adults with COPD and its European approval for maintenance of airflow in patients with COPD.

The phase 3 clinical trials involving umeclidinium included 7 studies and more than 2500 patients with COPD who were treated with either umeclidinium or placebo.

In seeking its approval in Europe, the company advised that the drug not be used in patients with asthma because it had not been tested in those patients, as well as patients with severe cardiovascular disorders. The company also advised against using the drug for the treatment of acute episodes of bronchospasm.

In addition, the company warns that caution is warranted in patients with narrow-angle glaucoma or urinary retention.

According to GlaxoSmithKline, the most common adverse reactions are nasopharyngitis, upper respiratory tract infection, cough, and arthralgia.

The company plans to launch the distribution of the treatment in the fourth quarter of this year.


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