FDA Panel Supports New Indication for GSK's Advair

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An FDA advisory committee has unanimously agreed that GlaxoSmithKline’s (GSK) Advair Diskus 500/50 demonstrated a significant reduction in the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD). The panel also found that Advair 500/50 provides substantial advantages over salmeterol in the treatment of patients with COPD.

The committee reviewed data from the TORCH study — currently the largest COPD study and the first to investigate whether a medication can affect both exacerbations and survival, according to GSK — and other supporting studies. The company submitted a supplemental new drug application to the FDA in October 2006 seeking marketing approval and expanded approval of Advair 500/50 (fluticasone propionate and salmeterol inhalation powder).

The panel voted 9-2 that the data presented did not provide substantial evidence to support the survival benefit, and that further data may be needed. It also recommended additional data to better understand the increased incidence of pneumonia among COPD patients treated with inhaled corticosteroids.

“We believe in the strength of the TORCH study and believe that the data show that Advair 500/50 provides important benefits for patients with COPD, including a reduction in the risk of dying,” Katharine Knobil, vice president of respiratory clinical development at GSK, said. “Therefore, we remain committed to working with the FDA as it reviews the supporting data from our clinical program.”

Advair Diskus 250/50 was approved in 2003 for the maintenance treatment of airflow obstruction associated with chronic bronchitis in patients with COPD.