GlaxoSmithKline (GSK) has obtained Japanese approval for its Encruse Ellipta (umeclidinium).
The Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval for the drug to provide relief from various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (COPD).
Encruse is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator that can improve airflow in and out of the lungs. It is a 62.5mcg strength inhalation powder that can be delivered in 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.
“Approval was based on a review of ten Phase III clinical trials, which comprised 4,000 COPD patients treated with umeclidinium or a placebo.”
“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.”
Approval was based on a review of ten Phase III clinical trials, which comprised 4,000 COPD patients treated with umeclidinium or a placebo.
According to GSK, 983 patients received the approved dose of umeclidinium 62.5mcg once-daily in these studies. The company plans to launch the product by the end of 2015 in Japan.
GSK also received MHLW approval for Duac Combination Gel (clindamycin 1%-benzoyl peroxide 3%) to treat acne vulgaris.
In addition, the company obtained approval for pneumococcal conjugate paediatric vaccine Synflorix to treat invasive infectious diseases and pneumonia caused by pneumococcus (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Developed by GSK, Synflorix was commercialised by Japan Vaccine, a joint venture of GSK and Daiichi Sankyo.