GlaxoSmithKline: Anoro Ellipta Gets Approval In Japan For Treatment Of COPD

(RTTNews) - GlaxoSmithKline plc (GSK.L, GSK) and Theravance Inc. (THRX) announced that the Japanese Ministry of Health, Labour and Welfare has approved Anoro Ellipta (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $10 million to GSK following the approval of UMEC/VI in Japan.

The approved dose in Japan is UMEC/VI 62.5/25mcg delivered once daily. The companies expect the launch will take place in Japan in the third quarter of 2014.

Anoro is a once-daily combination treatment comprised of two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta agonist (LABA), in a single inhaler, the Ellipta. The MHLW assessment of UMEC/VI involved a review of 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.