Theravance And GSK Receive Approval For Anoro Ellipta In Japan

Theravance and partner GlaxoSmithKline reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval to Anoro Ellipta (umeclidinium/vilanterol) for symptom relief in patients with chronic obstructive pulmonary diseases (COPD) in the country.

Anoro Ellipta is a once-daily combination therapy of two bronchodilators, umeclidinium (UMEC) and vilanterol (VI), in a single inhaler (Ellipta). UMEC is a long-acting muscarinic antagonist (LAMA) while VI is a long-acting beta2 agonist (LABA). The MHLW approved UMEC/VI in a 62.5/25mcg dose for the alleviation of COPD symptoms due to airway obstruction with chronic bronchitis or pulmonary emphysema in cases where concurrent use of LAMA and LABA is required.

Darrell Baker, SVP and Head of GSK Global Respiratory Franchise, 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.”

Rick E. Winningham, CEO of Theravance, 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.” Theravance will make a milestone payment of $10 million to GSK following the MHLW approval according to the 2002 LABA collaboration agreement.

In view of the approval, the companies expect to launch Anoro Ellipta in Japan in the third quarter of 2014.

The MHLW approved UMEC/VI based on its review of eight Phase III clinical trials including a safety study in Japanese patients. GSK and Theravance also recently announced their filing of approval for Breo Ellipta to the U.S. Food and Drug Administration (FDA). Breo Ellipta is a fixed dose combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2 agonist, as a once-daily treatment for asthma in patients 12 years old and above.