Canada has approved GSK’s Incruse Ellipta umeclidinium (UMEC) DPI for the once-daily treatment of COPD, the first approval for its UMEC monotherapy, the company said. GSK received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) regarding its MAA for Incruse Ellipta in February 2014, and the company submitted an NDA for the monotherapy to the FDA in April 2013.
The Anoro Ellipta DPI, which includes UMEC in combination with vilanterol, was approved in Canada in January 2104 and in the US in December 2013.
GSK Senior VP & Head, GSK Global Respiratory Franchise Darrell Baker commented, “COPD affects a significant and growing number of people globally. For over 40 years GSK has been at the forefront of research and development of new respiratory medicines, and our goal in COPD is to introduce a range of medicines so that physicians can choose the treatment option which best meets their individual patients’ needs. We are delighted that our LAMA monotherapy has achieved its first approval, and are now looking forward to progressing the ongoing regulatory submissions elsewhere.”
Read the GSK press release.
