GlaxoSmithKline announced that the FDA has approved Incruse Ellipta (umeclidinium) inhaler 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 a long-acting muscarinic antagonist (LAMA), referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.

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The approval of Incruse Ellipta is based on a Phase 3 clinical program that included 7 studies involving over 2,500 COPD patients treated with umeclidinium or placebo.

Incruse Ellipta is available as a 62.5mcg strength. It is expected to launch in 4th quarter of 2014.

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