GSK files new drug application in Japan for Seretide Diskus in asthma
GlaxoSmithKline plc (GSK) announced that it has filed Seretide Diskus for approval to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of asthma in adults and children. Seretide combines Serevent (salmeterol xinafoate), a long-acting beta 2-agonist and Flutide (fluticasone propionate), an inhaled corticosteroid, together in one easy to use inhaler.
Marc Dunoyer, president of GSK Japan said: "Seretide is already the world's number one asthma treatment and GSK's number one product, with worldwide sales in excess of £2 billion. We look forward to working with the MHLW to bring this treatment to those millions of asthma sufferers in Japan who will benefit from this treatment just as millions of other patients around the world benefit now."
Bronchial asthma is a two-component disease, consisting of both chronic airway inflammation and airway smooth muscle dysfunction, such as, bronchoconstriction. Seretide, in a single inhaler, treats both components of the disease.
Asthma claims around 4,000 deaths a year in Japan. Although this has been declining each year due to the increased use of inhaled corticosteroids, this number is still relatively high compared to other developed countries. GSK is committed to the research and development of asthma treatments helping patients achieve total control of their asthma.
Seretide has been available in over 100 countries worldwide for the treatment of asthma and is also currently approved for the treatment of Chronic Obstructive Pulmonary Disease (COPD) in over 60 countries. Serevent and Flutide are both marketed in Japan.