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news.GlaxoSmithKline has asked regulatory authorities in Europe to vary the label for top-selling asthma drug Advair to include results of the TORCH study, which the company claims shows benefits in treating chronic obstructive pulmonary disease.
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The drug, which is marketed as Seretide in Europe, is the company’s biggest product with $5.6 billion of sales last year. GSK said that the study, which assessed the medicine’s use in treating COPD, showed a 17.5% reduction in risk of death from any cause over three years for patients receiving Seretide compared with patients on placebo.
“We believe the results from the TORCH study are clinically important and that they will have a positive impact on the future management of COPD,” said Darrell Baker, senior vice president of GSK’s respiratory medicines development centre.
Seretide was associated with an increased reporting of adverse events classified under lower respiratory tract infections, when compared with placebo, but the company said that this did not compromise the overall benefit of Seretide seen in the study. Adverse events seen in the study generally appear consistent with those seen in previous studies of Seretide in patients with COPD.