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FDA approves GSK’s COPD drug

GlaxoSmithKline has announced that the FDA has approved Advair Diskus 250/50 for the reduction of exacerbations in patients with chronic obstructive pulmonary disease who have a history of exacerbations.

The FDA also expanded the use of Advair Diskus 250/50 to a broader patient population which includes not only patients with chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis, but also emphysema or both conditions.

According to the company, Advair 250/50 is the only approved strength for COPD in the US, because an efficacy advantage of the higher strength over Advair 250/50 has not been demonstrated.

Advair contains two medicines, an inhaled corticosteroid (fluticasone propionate) and a long-acting beta-agonist (salmeterol), that work together to improve lung function and reduce exacerbations, two primary goals in the management of COPD.