FDA approves GSK's Incruse Ellipta

LONDON — GlaxoSmithKline on Wednesday announced that the Food and Drug Administration approved Incruse Ellipta (umeclidinium), which is used for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and/or emphysema.



Umeclidinium is the company's first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonis and is contained in the Ellipta inhaler. The FDA-approved strength is 62.5-mcg.



“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," said Darrell Baker, SVP and head of GSK Global Respiratory Franchise.



GSK anticipates that launch activities in the United States will begin during fourth quarter 2014.