GSK gains extended European license for Seretide

GlaxoSmithKline (GSK) has announced that it has received an extended licence for Seretide 50/500 micrograms (salmeterol/fluticasone propionate) in Europe, with the compound now approved for use with a wider base of patients suffering from chronic obstructive pulmonary disease (COPD).

This change to the labelling of Seretide was approved by the European regulatory authorities last week, with the change to be implemented within individual European countries as part of the mutual recognition process.

According to the label change, the compound can be used earlier on in the course of COPD, with patients able to benefit from the drug before reaching more advanced stages of the condition.

Regulators have approved this change following a review of the Torch (Towards a revolution in COPD health) study data.

Darrell Baker, senior vice-president of the Respiratory Medicines Development Centre, said: “We are delighted that the European Agencies have extended the licence for Seretide to a broader patient population.”

He added that the company anticipated patients starting treatment with Seretide earlier on in the course of their illness and benefiting sooner from improvements in their lung function and quality of life.

In February 2007, GSK announced the publication of the Torch study results in the New England Journal of Medicine, while the company claimed that its results were “clinically important”, with researchers improving their understanding of COPD.