The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD, GlaxoSmithKline and Theravance have announced. In April 2013, the companies announced that they had submitted a marketing application to the MHLW. The approval triggers a $10 million milestone payment from Theravance to GSK.
GSK Global Respiratory Franchise Senior VP and Head Darrell Baker commented, “There are many people living with COPD in Japan whose ability to breathe is compromised by their condition. Our goal at GSK is to provide physicians with an expanded range of COPD medicines which enable a patient-centric approach to treatment, as recommended by global guidelines. We are delighted that Anoro Ellipta is now approved in Japan, making it the first GSK COPD treatment to gain Japanese regulatory approval in five years, and we believe it will be an important new once-daily dual bronchodilator treatment option for appropriate COPD patients.”
Theravance CEO Rick E Winningham said, “We are very pleased with this latest regulatory approval for Anoro Ellipta. This milestone is a further demonstration of the ongoing successful Theravance and GSK collaboration in respiratory medicine and we are looking forward to being able to make this new medicine available for appropriate COPD patients in Japan.”
According to the companies, Anoro Ellipta should launch in Japan in the third quarter of this year. The product was approved in the US in December 2013 and in Europe in May 2014.
Read the GSK/Theravance press release.
