GlaxoSmithKline receives Japanese approval for two major new product opportunities: Seretide/Advair and Arixtra

GlaxoSmithKline (GSK) today announced that it has received approval for Seretide/Advair Diskus (salmeterol and fluticasone proprionate combination) and Arixtra (fondaparinux sodium) from the Ministry of Health, Labour and Welfare in Japan.


Seretide/Advair, which will be marketed as Adoair Diskus 50/100mcg, 50/250mcg and 50/500mcg, has been approved for adult patients with bronchial asthma when concomitant use of an inhaled corticosteroid and long-acting beta-agonist is necessary. Adoair will be the only combination respiratory medicine available in Japan, targeting both inflammation and bronchoconstriction, the two main components of asthma.


According to estimates, around 4.5 million Japanese have bronchial asthma, with around 40% suffering from moderate to severe asthma. Asthma was designated a Health Priority by the Japanese Ministry of Health, Labour and Welfare in 2006.


The anti-thrombotic Arixtra has been approved as a once-daily subcutaneous injection (1.5mg and 2.5mg), for the prevention of venous thromboembolic events (VTE) in patients who are at high risk for VTE undergoing major orthopaedic surgeries of the lower limb. Arixtra was designated as a priority review product by the Japanese authorities in February 2006 and is the first anti-thrombotic agent to be approved for the prevention of VTE since the approval of unfractionated heparin in 1972.


“We are delighted that Seretide/Advair has received approval in Japanas many respiratory specialists are already aware of the benefits of this gold standard treatment and are eagerly awaiting its launch.” said David Stout, President of Pharmaceutical Operations, GSK. “We expect sales of Seretide/Advair in Japanwill make a significant contribution to worldwide sales of this important GSK product. The additional news, that Arixtra is also approved today, as the first new agent for VTE for many years, is further evidence of a strong product pipeline coming to fruition in this key international market.”