GlaxoSmithKline has received approval in Japan for its key respiratory product Seretide/Advair Diskus and its anti-thrombotic Arixtra, a move which the company says should make a significant contribution to worldwide sales.
Seretide/Advair (fluticasone and salmeterol), which will be marketed as Adonair Diskus 50/250mcg and 50/500mcg, has been approved for adult patients with bronchial asthma when use of an inhaled corticosteroid and long-acting beta-agonist is necessary. The company says this will be the only combination respiratory medicine available in Japan targeting both inflammation and bronchoconstriction, the two main components of asthma.
It is thought that around 4.5 million suffer from bronchial asthma in Japan, with around 40% having moderate-to-severe symptoms. The condition was designated a health priority by the Japanese Ministry of Health, Labour and Welfare in 2006.
GSK’s anti-thrombotic Arixtra (fondaparinux sodium) has been cleared as a once-daily subcutaneous injection of 1.5mg and 2.5mg for the prevention of venous thromboembolic events (VTE) in patients who are at high risk when undergoing major orthopaedic surgeries of the lower limb. The drug was designated a priority review product by Japanese authorities in February last year, and is the first antithrombotic agent to be approved for the prevention of VTE since unfractionated heparin in 1972.
Giving a boost to global sales
Commenting on the approvals, David Stout, president of Pharmaceutical Operation at GSK, said: “We expect sales of Seretide/Advair in Japan will 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.”
As reported in February, first-quarter figures for Seretide/Advair showed sales growth just under double-digit figures, of 9%, at £862 million. At the time GSK noted positive new data from the TORCH trial, a COPD mortality study which was recently filed with regulators, which observers believe will give a further lift to the product’s sales.