GlaxoSmithKline receives approval for Advair Diskus 250/50

May 2, 2008

GSK's fluticasone/salmeterol combination powder is apporved by FDA for reduction in COPD exacerbations.

Advair Diskus 250/50, from GlaxoSmithKline, may now be used for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. The combination drug, which contains fluticasone propionate 250 mcg and salmeterol 50 mcg, was proven effective for this new indication in two one-year clinical trials involving a total of 1,579 patients. Patients treated with Advair had a 30% reduction in the rate of annual exacerbations compared with salmeterol (p<0.001) and a significantly lower annual rate of exacerbations requiring treatment with oral corticosteroids (p<0.001). According to GSK, the new approval expands the use of the inhalation powder to include patients with emphysema in addition to chronic bronchitis, which was the target population of the product’s original approval back in 2003.

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