Less than a week after the approval of GSK’s Incruse Ellipta umeclidinium DPI in Europe, the company has announced that the FDA has approved the product for the treatment of COPD and it expects to launch Incruse Ellipta in the US by the end of the year. GSK submitted the NDA for umeclidinium monotheraphy at the end of April 2013.
GSK Global Respiratory Franchise Senior VP and Head Darrell Baker commented, “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.”
Incruse Ellipta was also approved in Canada in April 2014, and GSK says that applications are undergoing review in additional countries.
Read the GSK press release.
