FDA Approves Umeclidinium for Long-term Management of Chronic Obstructive Pulmonary Disease

The US Food and Drug Administration (FDA) has approved Incruse Ellipta (umeclidinium) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Umeclidinium is an anticholinergic drug, a type of bronchodilator also known as a long-acting muscarinic antagonist. It is approved for delivery via inhaler at a dose of 62.5 mcg.

In a news release announcing the approval of Incruse Ellipta, GlaxoSmithKline stated the drug “will be an important once-daily treatment option for appropriate patients with COPD.”

The drug has been approved in Canada for the treatment of COPD in adults, and in Europe for maintenance of airflow in patients with COPD.

FDA approval was based on data from seven clinical studies that involved more than 2,500 patients with COPD who were treated with umeclidinium or placebo.

The company recommends against using umeclidinium in patients experiencing rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm.

According to GSK, the drug should also “be used with caution” in patients with narrow-angle glaucoma or urinary retention. The most common side effects associated with umeclidinium treatment are nasopharyngitis, upper respiratory tract infection, cough, and arthralgia.