The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved GlaxoSmithKline's Encruse Ellipta (umeclidinium) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema) (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. Encruse is a 62.5mcg strength inhalation powder delivered in the Ellipta inhaler.
Darrell Baker, SVP & head, GSK Global Respiratory Franchise, said, “We are proud of this approval for Encruse Ellipta as it means healthcare professionals in Japan will have another treatment option for appropriate COPD patients. 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.”
Following this approval, it is expected that launch will take place in Japan in 2015.
The MHLW assessment of umeclidinium included a review of ten phase III clinical trials which included approximately 4,000 COPD patients treated with umeclidinium or placebo. Within this, 983 patients received the approved dose of umeclidinium 62.5mcg once-daily.
The MHLW also announced the approval of Duac combination gel in Japan, for use in the treatment of acne vulgaris. Duac combination gel (clindamycin 1%-benzoyl peroxide 3%) is the first fixed-dose combination topical treatment for acne in Japan.
Synflorix, a pneumococcal conjugate paediatric vaccine, was also approved by the MHLW, 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). Synflorix was developed by GSK and is commercialised by Japan Vaccine Co., Ltd., a joint venture between GSK and Daiichi Sankyo Co., Ltd.