GlaxoSmithKline PLC
23 May 2003
Issued - London, United Kingdom 23 May 2003
GLAXOSMITHKLINE RECEIVES APPROVAL FROM THE EUROPEAN COMMISSION FOR SERETIDE(TM)
DISKUS(TM) FOR THE TREATMENT OF COPD
GlaxoSmithKline plc (LSE and NYSE: GSK) announced today that they have received
an approval from the European Commission for the use of SeretideTM (Seretide
Diskus 50/500, a combination of long-acting beta2-agonist, salmeterol and
inhaled corticosteroid, fluticasone propionate) as a new treatment for patients
with severe chronic obstructive pulmonary disease (COPD). Seretide is indicated
for the symptomatic treatment of patients with severe COPD (FEV1<50% predicted
normal) and a history of repeated exacerbations, who have significant symptoms
despite regular bronchodilator therapy. Each EU Member State will now review the
decision and grant a local language version of the approval.
"Today's approval of Seretide for COPD by the European Commission is not only a
milestone for GSK, the world leader in respiratory medicine, but also for the
millions of COPD patients in Europe. GSK is committed to fighting this
debilitating disease and will continue to invest in research and development to
improve the everyday lives of these sufferers", said Andrew Witty, President,
Pharmaceuticals, Europe at GSK.
COPD is a major health concern in Europe, where it is the fifth largest
killer(1)and effects an estimated 340 million sufferers world-wide(2). COPD, a
multi-component disease, remains highly undiagnosed and is the only leading
cause of death in the world to be increasing in prevalence(3).
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer.
Seretide should be used with caution in patients with severe cardiovascular
disorders. Some patients may experience an increase in heart rate or changes in
heart rhythm.
For additional information, please refer to the full prescribing information for
Seretide.
S M Bicknell
Company Secretary
23 May 2003
-ENDS-
Notes to Editors:
Salmeterol / fluticasone propionate combination is marketed as SeretideTM
DiskusTM in most European countries and as SeretideTM AccuhalerTM in the United
Kingdom and is indicated for the treatment of asthma in adults and children
(over the age of four years for the Accuhaler in the United Kingdom) for whom
treatment with both inhaled corticosteroid and a long-acting beta2-agonist is
appropriate. The licence varies depending on the country and it is recommended
that journalists seek advice from the relevant GlaxoSmithKline local operating
company.
Enquiries:
UK Media enquiries: Martin Sutton (020) 8047 5502
David Mawdsley (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patricia Seif (215) 751 7709
European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Philip Thomson (020) 8047 5543
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
References:
1.Murray CJL, Lopez AD. Eds. The Global Burden of Disease: a comprehensive
assessment of mortality and disability from diseases, injuries, and risk factors
in 1990 and projected to 2002. Cambridge; Harvard University Press; 1996.
2. The World Health Report 1998. Life in the 21st Century. A vision for all.
World Health Organisation, Geneva, 1998.
3. NHLBI/WHO Workshop Report. Global Initiative for Chronic Obstructive Lung
Disease. Global Strategy for the diagnosis, management and prevention of chronic
obstructive pulmonary disease, 2001.
This information is provided by RNS
The company news service from the London Stock Exchange
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