GlaxoSmithKline (GSK) and Theravance have obtained approval from the Japanese Ministry of Health, Labour and Welfare for Anoro Ellipta to treat chronic obstructive pulmonary disease (COPD).

The Japanese approval for Anoro Ellipta is for the relief of various symptoms due to airway obstruction with COPDs, in the case where concurrent use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required.

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Anoro is a once-daily combination treatment comprised of two bronchodilators, umeclidinium and vilanterol, in a single inhaler, the Ellipta.

Umeclidinium is a long-acting muscarinic antagonist, while vilanterol is a long-acting beta2 agonist. The approved dose in Japan is umeclidinium/ vilanterol 62.5/25 micrograms.

Approval of Anoro Ellipta in Japan is supported by data from eight phase III clinical trials, evaluating approximately 6,000 COPD patients worldwide, including a specific 52 week, open-label, long-term safety study in Japanese patients.

"We believe it will be an important new once-daily dual bronchodilator treatment option for appropriate COPD patients."

GSK Global Respiratory Franchise senior vice-president and head Darrell Baker said: "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: "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."

In 2002, Theravance entered into a long-acting beta2 agonist (LABA) collaboration with GSK to develop and commercialise a once-daily LABA product candidate either as a single agent or in a combination medicine for treatment of asthma and COPD.

Under the terms of the collaboration agreement, Theravance is obligated to make a milestone payment of $10m to GSK following the Japanese approval of UMEC/VI. Following approval, it is expected that launch will take place in Japan in the third quarter of 2014.

Image: GlaxoSmithKline headquaters in Brentford, England. Photo: courtesy of Maxwell Hamilton.