GlaxoSmithKline (GSK) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Encruse Ellipta (umeclidinium) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (COPD).
Encruse is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator which can relax airway muscles and improve airflow in and out of the lungs.
The company said that Encruse contains 62.5mcg umeclidinium and is delivered by the Ellipta inhaler.
GSK Global Respiratory Franchise senior vice-president and head Darrell Baker said: "Encruse is our first LAMA monotherapy and the second treatment from our new COPD portfolio to be approved in Japan within the last year.
"The Ellipta inhaler has been positively received by physicians in Japan and today’s approval reflects our goal of providing a range of respiratory medicines in a consistent inhaler that enables physicians to meet the specific needs of individual patients."
The approval was based on data from ten Phase III clinical trials which included around 4,000 COPD patients treated with umeclidinium or placebo.
In these trials, a total of 983 patients received the approved dose of umeclidinium 62.5mcg once-daily.
Following this approval, the company expects the launch to take place in Japan in 2015. In addition, the company’s two further products Duac combination gel and Synflorix also secured approval in Japan.
Duac Combination Gel (clindamycin 1%-benzoyl peroxide 3%) is the first fixed-dose combination topical treatment for acne vulgaris in Japan.
Synflorix, a pneumococcal conjugate paediatric vaccine, was approved with an indication for the prevention of invasive infectious diseases and pneumonia caused by pneumococcus (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
GSK was responsible for the development of Synflorix, which is commercialized by Japan Vaccine, a joint venture between GSK and Daiichi Sankyo.
Image: GlaxoSmithKline (GSK) headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.