Glaxo gets approval for two drugs in Japan

Advair, which will be marketed as Adoair Diskus, 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.

Asthma was designated a health priority by the Japanese Ministry of Health, Labor and Welfare in 2006.

Japan also approved Arixtra, an anti-thrombotic agent, as a once-daily subcutaneous injection, for the prevention of venous thromboembolic events (VTE) in patients who are at high risk for VTE undergoing major orthopedic surgeries of the lower limb.

“We expect sales of 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,” said David Stout, president of Pharmaceutical Operations, GSK.