European regulators have expanded the number of patients eligible for treatment with GlaxoSmithKline’s chronic obstructive pulmonary disorder drug Seretide.
The corticosteroid/bronchodilator combination Seretide (salmeterol/fluticasone propionate) is now available to patients with COPD whose measure of lung function is <60% of the predicted normal function before administering a bronchodilator, and who have significant symptoms despite therapy.
Approval was based on a review of data from the landmark TORCH clinical trial; the largest prospective, randomised, placebo-controlled pharmacotherapy study ever carried out in COPD, according to the firm. This showed that Seretide improved survival rates, cut the rate of exacerbations by 25%, and that patients experienced an improvement in health related quality of life and FEV1 compared to those receiving placebo.
Before regulators agreed to the label extension, it was only when a patient’s lung function had deteriorated to an FEV1 (forced expiratory volume in one second) of <50% than predicted that the drug could be prescribed. Therefore, the new indication will give more COPD patients access to Seretide earlier in the course of the disease.
Better quality of life
“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,” commented Darrell Baker, senior vice president of GSK’s Respiratory Medicines Development Centre.
By 2020, COPD is projected to be the third leading cause of death and fifth leading cause of disability worldwide after ischaemic heart disease, depression, traffic accidents and cerebrovascular disease, and is estimated to kill more than 250 people per hour worldwide, the firm notes.