GSK receives extended licence indication for Seretide in Europe following submission of TORCH data for COPD
Not for distribution to US media
Issued – Monday 9 July 2007, London, UK
GSK announced today that it 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% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.1 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% 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% (p=0.052), 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% (p<0.001) 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 (p<0.001).2
The typical COPD patient experiences a decline in health status over time.3,4 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.2
The Seretide label will also include additional advice to healthcare professionals about undesirable effects including upper respiratory tract infections and increased risk of lower respiratory tract infections, including pneumonia.
The Seretide label change was approved by the European Regulatory Authorities involved in the mutual recognition process on 5 July 2007. This change will come into effect within individual countries following update of national labels and patient information.
About GlaxoSmithKline
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.
Enquiries:
| UK Media enquiries: | Philip Thomson | (020) 8047 5502 |
| Claire Brough | (020) 8047 5502 | |
| Joss Mathieson | (020) 8047 5502 | |
| Gwenan White | (020) 8047 5502 | |
| European Analyst/Investor enquires | David Mawdsley | (020) 8047 5564 |
| Sally Ferguson | (020) 8047 5543 |
Notes to editors:
The European Countries involved in this process include: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, UK.
About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and potentially fatal disease, but it can be both prevented and treated. The disease has a number of different components causing limitations to airflow in the lungs and breathing difficulties. These include increased inflammation in the airways, direct damage and structural changes to the lungs and reduced body mass, weakness and wasting, which affect the health status of the person and ultimately their survival. Improving survival remains a major unmet need for patients with COPD.2
By 2020 COPD is projected to be the third leading cause of death and fifth leading cause of disability worldwide following only ischaemic heart disease, depression, traffic accidents and cerebrovascular disease.5 COPD is estimated to kill more than 250 people per hour worldwide.6
About TORCH
TORCH (TOwards a Revolution in COPD Health) is the first and largest study to prospectively investigate the potential for Seretide (salmeterol/fluticasone propionate, SFC) 50/500 µg to impact survival in patients with Chronic Obstructive Pulmonary Disease (COPD). TORCH is a three year, multicentre, randomised, double-blind, parallel group placebo controlled study. Approximately 6,100 patients, who were 40 – 80 years of age who had a diagnosis of COPD, with pre bronchodilator forced expiratory volume in 1 second (FEV1) of< 60% and 10% reversibility of predicted FEV1,meeting the European Respiratory Society definitions for COPD were randomised from 439 sites in 42 countries to one of the following 4 treatment groups:2
- Placebo
- Salmeterol (50 µg)
- Fluticasone propionate (500 µg)
- Seretide (SFC, 50/500 µg), all inhaled twice daily via the Diskus™
In all treatment arms patients were allowed to take other medications to treat COPD symptoms including anticholinergics, theophylline and salbutamol (similar usage was seen across treatment arms). Patients were instructed not to take inhaled corticosteroids, long term oral corticosteroids or long-acting bronchodilators while enrolled in the study.
The primary end point of TORCH was the reduction in all-cause mortality, comparing SFC with placebo. Secondary endpoints include:2
- COPD morbidity (as measured by the rate of exacerbations [moderate requiring systemic corticosteroids and/or antibiotics or severe requiring hospitalisation])
- Quality of life (as measured by St George’s Respiratory Questionnaire (SGRQ))
In the TORCH trial, published in the New England Journal of Medicine, the reduction in all-cause mortality between SFC and placebo groups did not meet the pre-specified significance level. In the NEJM paper, the authors suggest that the lower than anticipated number of deaths and the high withdrawal rate in patients receiving placebo, who were free to receive active therapy subsequently, including Seretide, may have contributed to the final results not reaching statistical significance.2
About Seretide / Advair
The brand name for fluticasone propionate / salmeterol in the European Union (excluding Germany) is Seretide. The brand name of fluticasone propionate / salmeterol in Germany is Viani™. The brand name for fluticasone propionate / salmeterol in the US is Advair.
Seretide is a combined treatment of fluticasone propionate, an inhaled corticosteroid and salmeterol, a long acting bronchodilator. Each component targets different aspects of the pathophysiology of COPD a multi-component disease with inflammation at the core.
The inflammation seen in patients with COPD is present even in the early stages of the disease and is associated with disease progression.7 Seretide has been shown to have a broad range of anti-inflammatory effects in COPD which are greater than those seen with inhaled corticosteroids (ICS) in single treatment.8,9
Seretide / Viani 50/500 is licenced in the European Union for the symptomatic treatment of patients with severe COPD (forced expiratory volume in one second FEV1 < 60% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Seretide/Viani 50/500 has common adverse events on the European label listed as: Candidiasis of the mouth and throat, Pneumonia, Bronchitis, Hypokalaemia, Headache, Tremor, Palpitations, Nasopharyngitis, Throat irritation, Hoarseness/dysphonia, Sinusitis, Contusions, Muscle cramps and Traumatic fractures
Advair 50/250 is licenced in the US for twice-daily maintenance treatment of airflow obstruction in patients with COPD associated with bronchitis. Advair Diskus 50/250 is the approved dose for treatment of COPD in the US. Advair Diskus does not have a licence for 50/500 for the treatment of patients with COPD.
Seretide/Advair 50/250 and 50/500 is approved for the treatment of COPD in over 40 additional countries including Australia, Canada, Mexico and Turkey.
References
1. Final Variation Assessment Report Seretide Diskus/Viani Diskus Seretide Evohaler/Viani Evohaler (fluticasone propionate/salmeterol xinafoate)
2. Calverley, PMA et al on behalf of the TORCH investigators. Salmeterol and fluticasone propionate and survival in Chronic Obstructive Pulmonary Disease. NEJM 2007; 356: 775-789
3. Thompson WL. Pulmonary Disease. In: Stoudemire A, Fogel BS, Greeberg DB, eds. Psychiatric care of the medical patient. 2nd ed. New York, NY: OxfordUniversityPress; 2000:757-774.
4. Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, StanleyMA. Surprisingly High Prevalence of Anxiety and Depression in Chronic Breathing Disorders. Chest 2005; 127;1205-1211
5. European Respiratory Society, European Lung Federation, European Lung White Book, 2003.
6. WHO. The World Health Report 2002. Reducing risks, promoting healthy life. MDI.WHR.202.A. Geneva, The World Health Organization; 2002
7. Hogg JC, ChuF. The Nature of Small-Airway Obstruction in Chronic Obstructive Pulmonary Disease. NEMJ 2004; 350;26
8. Yamauchi Y, Christodoulopoulos P, Olivenstein R, Maltais F, Bourbeau J, Hamid Q. The Effect of Salmeterol/Fluticasone Combination on Airway Inflammation in COPD Compared to Fluticasone. PATS 2006; 3(abstracts issue): A113
9. Barnes N, Qiu Y, Pavord I et al. Antiinflammatory Effects of Salmeterol/Fluticasone Proprionate in Chronic Obstructive Lung Disease.
Am J Respir Crit Care Med 2006; 173: 736-743
