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New drug treatment for COPD receives FDA approval

May 1, 2014
by Sandra Hoban, Managing Editor
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The Food & Drug Administration (FDA) has approved umeclidinium 62.5 mcg (Incruse Ellipta), an anticholinergic agent, for the long-term treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The drug is a once-daily maintenance treatment of airflow obstruction delivered via inhaler, according to a GlaxoSmithKline (GSK) news release.

Umeclidinium was approved following the results of a phase 3 pivotal program that included seven clinical studies and more than 2,500 patients who have COPD.

GSK expects that launch activities in the United States will begin in the fourth quarter of this year.

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