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10 February 2003
ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR SYMBICORT® TURBUHALER® IN COPD IN THE EUROPEAN UNION

AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in the European Union for the use of the SYMBICORT® TURBUHALER® in the maintenance therapy of chronic obstructive pulmonary disease (COPD) in patients with severe COPD and a history of exacerbations. Sweden acted as the reference member state. SYMBICORT is already a leading therapy in the treatment of asthma, and is now set to gain European approval as a combined ß2-agonist and inhaled corticosteroid treatment for COPD.

"SYMBICORT will provide physicians with an effective and convenient treatment option for the long-term treatment of COPD,” said Dr Anders Ekblom, Vice President and Head of the Respiratory and Inflammation Therapy Area, AstraZeneca. “Patients with COPD stand to benefit from a substantially reduced risk of exacerbations, which are a major cause of medical intervention (including hospitalisations) and patient distress. SYMBICORT provides clinically meaningful benefits and, therefore, has the potential for reducing the burden of the disease.”

SYMBICORT TURBUHALER is a dry powder inhaler providing both the rapid-acting and long-lasting bronchodilator OXIS® (formoterol) and the anti-inflammatory inhaled corticosteroid PULMICORT® (budesonide) in a single inhaler. In COPD patients, SYMBICORT will be given at a dose of one inhalation of budesonide/formoterol 320/9µg twice daily. In 2002, sales for SYMBICORT totalled $299 million.

There are an estimated 600 million people with COPD worldwide. It is the fourth leading cause of death in the industrialised world. The global market for COPD drugs is anticipated to amount to more than $9 billion in 2010.

SYMBICORT was studied in two 12-month clinical trials conducted in patients with COPD (FEV1 less than or equal to 50% predicted normal) and a history of exacerbations. SYMBICORT significantly reduced the risk of exacerbations, improved lung function, and provided rapid and sustained symptom relief. SYMBICORT demonstrated significant benefit compared to long-acting bronchodilator treatment alone, prolonging the time to first exacerbation, reducing the relative risk of exacerbating and reducing the need for intervention with oral steroids by 30 per cent compared to formoterol alone

Patients treated with SYMBICORT will have the confidence to return to everyday activities with less worry of exacerbations. Clinical trial data showed that using SYMBICORT provided a meaningful improvement in COPD patients’ quality of life.

SYMBICORT meets the international guidelines laid down by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), endorsed by the World Health Organisation and US National Heart Lung and Blood Institute, for the treatment of patients with severe COPD and a history of exacerbations.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

For more information on Symbicort® or AstraZeneca’s respiratory portfolio, visit www.Symbicort-Newscentre.com

Further enquires to:

Media Enquiries

Emily Denney
+44 (0)20 7304 5034

Steve Brown
+44 (0)20 7304 5033


Investor Relations

Mina Blair-Robinson
+44 (0)20 7304 5084

Jonathan Hunt
+44 (0)20 7304 5087


Note to News Editors:

  • European Union members are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom.
  • COPD is a progressive and disabling disease characterised by airflow obstruction that is not fully reversible, and by symptoms such as dyspnoea, breathlessness, cough and sputum hypersecretion. COPD tends to develop in middle age in long-term smokers.
  • In the UK market, formoterol is eformoterol and TURBUHALER® is TURBOHALER®.

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