GSK has been granted a licence extension in Europe for Seretide 50/500µg (salmeterol/fluticasone propionate) for use in a broader population of patients with the lung disease COPD. This follows a regulatory review of the TORCH (Towards a Revolution in COPD Health) study data by the European Regulatory authorities.
Darrell Baker, SVP respiratory medicines development centre said, "We are delighted that the European Agencies have extended the licence for Seretide to a broader patient population. We hope, and expect, that this will mean that patients presenting to their healthcare professional start to use Seretide earlier and benefit from improvements in quality of life and in their lung function, before they have reached the severe stage of the disease."
Seretide is now indicated for the symptomatic treatment of patients with COPD, FEV1 <60 per cent predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy Forced expiratory volume in one second (FEV1), is a way of measuring the lung function of patients with COPD. A higher percentage indicates better lung function.
Prior to the label update, it was only when a patient's lung function had deteriorated to an FEV1 of <50 per cent predicted, that Seretide was indicated for use. This new indication means that more COPD patients may be able to use Seretide earlier in the course of the disease and benefit from improvements in quality of life and in lung function, before they reach the more severe stage of the disease. This label captures a broader range of COPD patients eligible for treatment with this type of combination therapy.
The application was approved following consideration of the results of the landmark TORCH study; the largest prospective, randomised, placebo-controlled pharmacotherapy study ever carried out in COPD. In addition to a relative risk reduction in mortality of 17.5 per cent, which was just outside the predetermined level of statistical significance of p<0.05, TORCH showed that Seretide reduced the rate of exacerbations by 25 per cent compared to placebo and that patients treated with Seretide showed an improvement in health related quality of life (HRQoL) and FEV1, when compared with patients receiving placebo, over the three years of the study.
The typical COPD patient experiences a decline in health status over time. Patients receiving Seretide in the TORCH study showed an improvement in their health status over the three years and at the end of the study remained above the baseline that they started from at the beginning of the study.