GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA) has approved 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.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “We believe Incruse Ellipta, our first monotherapy in the anticholinergic class, will be an important once-daily treatment option for appropriate patients with COPD. GSK has a long-standing commitment to the development of respiratory medicines in order to offer physicians a choice of treatment options for their patients. We are delighted by this approval, and are looking forward to making Incruse Ellipta available for appropriate patients with COPD in the US.”
Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the fourth quarter of 2014.The phase III pivotal programme for umeclidinium included seven clinical studies which involved over 2,500 COPD patients treated with umeclidinium or placebo.
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.
Ellipta is an anticholinergic approved in the US 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. Incruse contains 62.5 mcg umeclidinium delivered by the Ellipta inhaler.
In April 2014, Canada’s regulatory authority Health Canada approved Incruse Ellipta in Canada for the treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. Also in April 2014, the European Commission granted marketing authorisation for Incruse in Europe as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Regulatory applications for umeclidinium have been submitted and are undergoing assessment in a number of other countries. Incruse and Ellipta are trademarks of the GSK group of companies.
In April 2014, Canada’s regulatory authority Health Canada approved Incruse Ellipta in Canada for the treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
Also in April 2014, the European Commission granted marketing authorisation for Incruse in Europe as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Regulatory applications for umeclidinium have been submitted and are undergoing assessment in a number of other countries.
Incruse and Ellipta are trademarks of the GSK group of companies.