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4 January 2001
SYMBICORT® GAINS EUROPEAN UNION MUTUAL RECOGNITION APPROVAL FOR ASTHMA CONTROL

AstraZeneca announced today that Symbicort®, a new and innovative treatment for asthma, has been granted approval through the Mutual Recognition Procedure (MRP) in 14 European Union (EU) states plus Norway and Iceland. This follows initial approval of Symbicort in Sweden in August 2000. Sweden acted as the reference member state for the MRP application. In addition to these approvals, Symbicort has been approved in Switzerland, and applications have been submitted in both Canada and Australia.

Symbicort contains the corticosteroid budesonide and the rapid- and long-lasting bronchodilator, formoterol, in the same single inhaler, Turbuhaler®. Both of these classes of treatments are needed to manage effectively many patients with asthma. However, this is the first time these two successful treatments have been teamed up in one single inhaler, thereby increasing convenience for patients and potentially increasing adherence to prescribed therapy.

Because of the variable nature of chronic asthma, management guidelines highlight the need to start at a high dose of inhaled corticosteroid in order to gain control of asthma, then step down to the lowest possible dose -- even including once daily -- when the disease is fully controlled  [1]. The need for adjustable dosing has meant that, up until now, doctors have often had to prescribe a new inhaler (and patients have had to purchase a new inhaler) with each new dose or treatment required. Symbicort is the first and only inhaler containing a corticosteroid and a rapid- and long-lasting bronchodilator that provides prescribers with the unique benefit of being able to start at a high dose and then, depending on how the patient responds, step down or back up using the same single inhaler.

Dr Colin Reddrop, AstraZeneca Vice-President and Head of Respiratory and Inflammation Research and Development (R&D), said: "The EU approval of Symbicort is exciting news and I am delighted that we can now offer asthma patients, many of whom are not yet well controlled, an increase in treatment freedom. Both doctors and patients will be able to benefit from this simplified regimen that encourages adherence to asthma treatment. We think this will provide long-term, real-life clinical benefits that extend beyond those achieved when two separate inhalers are prescribed."

Symbicort has been shown to improve significantly the rate of exacerbations and asthma control in patients not fully controlled on inhaled corticosteroids alone  [2],  [3]. These findings corroborate those of the landmark study by Pauwels et al, published in the New England Journal of Medicine. This study showed that when budesonide and formoterol are used together in patients with moderate to severe asthma, the rate of mild and severe asthma attacks can be reduced by as much as 62 and 63 percent, respectively. In addition, improvements were seen in patients' lung function and night-time symptoms. Such benefits provide a significant and sustained improvement in patients' quality of life  [4].

Symbicort is available in the new Turbuhaler® , which has a numerical dose counter and a redesigned patient-friendly mouthpiece.

Symbicort is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (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 $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.

Further enquires to:



Lucy Williams
+44 (0)20 7304 5034

Steve Brown
+44 (0)20 7304 5033


[1] Global Initiative for Asthma (GINA). Pocket guide for Asthma Management and Prevention. 1998

[2] Zetterström O, Buhl R, Mellem H, Perpina M, Hedman J, O'Neill S, Peterson S. Symbicort® (budesonide and formoterol in a single inhaler) improves asthma control in adults: a randomised controlled study Eur Resp J 2001 (in press).

[3] Zetterström O, Buhl R, Mellem H, Perpiña M, Hedman J, O'Neill S, Peterson S. The new single inhaler product containing both budesonide/formoterol improves asthma control in adults. Eur Respir J 2000;16 (Suppl 31):455s + poster.

[4] Pauwels RA et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. NEJM. 1997;337 (20): 1405-1411.


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