US Launch of GSK's Incruse Ellipta Expected for Q4 of 2014

In April 2014, GlaxoSmithKline plc (LSE/NYSE: GSK) announced FDA approval of Incruse Ellipta (umeclidinium) as an anticholinergic indicated 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 GSK’s first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA), and is contained in the Ellipta inhaler. The FDA-approved strength is 62.5 mcg.

It is anticipated that launch activities of Incruse Ellipta will commence in the United States during the fourth quarter of 2014.

About COPD

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the US alone are affected by COPD.

According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. In the United States, the most common irritant that causes COPD is cigarette smoke. Breathing in second-hand smoke, air pollution, chemical fumes, or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

About Incruse Ellipta

Incruse Ellipta is an anticholinergic approved in the United States for the long-term once-daily maintenance treatment of airflow obstruction in patients with (COPD), including chronic bronchitis and/or emphysema. Incruse contains 62.5 mcg umeclidinium delivered by the Ellipta inhaler.