GSK ‘believes in strength of Advair data’

GlaxoSmithKline (GSK) has reported that it has confidence in the robustness of the data of its chronic obstructive pulmonary disease (COPD) studies involving Advair Diskus (fluticasone propionate and salmeterol inhalation powder) 500/50.

The company has expressed disappointment with the US Food and Drug Administration (FDA) decision to issue a not-approval letter for the 500/50 strength of the compound.

It notes that this decision comes despite a vote from the FDA advisory committee earlier this year reaffirming the efficacy of Advair 500/50 in reducing the risk of exacerbations in patients.

Katharine Knobil, vice-president of respiratory clinical development for COPD at GSK, said: “We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years.”

She added that the firm would work together with the FDA in order to tackle any issues the regulator may have with the application.

The firm will meet with the FDA and discuss its concerns regarding how Advair 500/50 compares to the existing 250/50 strength product in order to facilitate suitable dosing recommendations for patients.

In March 2007, a study published in the Annals of Internal Medicine journal claimed that while Advair can improve lung function when used in conjunction with Boheringer Ingelheim’s Spiriva, it does not reduce exacerbations in patients with COPD.