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| 17 November 2003 | 2003-11-17T00:00:00.0000000-00:00 |
| ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR HIGH DOSE RANGE OF SYMBICORT® TURBUHALER®
AstraZeneca announced today that it has successfully completed the European Union Mutual Recognition Procedure for Symbicort® Turbuhaler®, which permits the use of an increased dose range in some patients with persistent asthma. National licences are expected to be issued throughout the EU over the coming months and will allow patients to use up to four inhalations twice daily of the 80/4.5mg and 160/4.5mg strengths (or two inhalations twice daily of the 320/9mg strength). | The increased dose range of the 80/4.5mg and 160/4.5mg strengths is already approved in Canada, Switzerland, New Zealand and Mexico, and is within the label of the Symbicort® Turbuhaler® monocomponents, budesonide and formoterol, in many countries. Upon the granting of national licences, prescribers and patients in EU countries will have a wider range of Symbicort® dosing options.
Asthma is a variable disease. Patients experience periods of good control, but exposure to external factors can often trigger periods of worsenings, which can develop into “asthma attacks”. Several recent clinical trials including more than 2,500 patients have demonstrated that, while regular, fixed doses of combination products provide good control of persistent asthma, patients can also prevent asthma attacks more effectively by temporarily increasing their Symbicort® dosage when symptoms increase and reducing it during periods of good control.
This treatment concept is simple for patients to follow and helps to prevent worsening of symptoms developing into distressing asthma attacks. For example, a prescriber could initiate Symbicort® therapy at two inhalations twice daily. The patient could then reduce to perhaps one inhalation twice daily during periods of good control and increase the dosage up to four inhalations twice daily if their condition worsens. The prescriber has the discretion to adjust the dose of Symbicort® within the approved dosing range.
Symbicort® is the only combination treatment that allows patients to adjust their dose with the same single inhaler. Recent studies have also shown that despite having the option to increase their dose to eight inhalations a day to prevent these attacks, patients using Symbicort® adjustable maintenance dosing used fewer inhalations than patients on a fixed dose of two inhalations twice daily.
In a recently published study comparing Symbicort® adjustable maintenance dosing with both Symbicort® fixed dosing (160/4.5mg) and fixed dosing of Seretide® (salmeterol/fluticasone) dry powder inhaler (DPI) (50/250mg bid), all groups were shown to provide an equal number of well-controlled asthma weeks. However, the possibility to immediately double or quadruple daily doses on signs of asthma worsening using Symbicort® adjustable maintenance dosing, decreased severe asthma exacerbations by 40 per cent, compared with fixed dose Seretide® (salmeterol/fluticasone) DPI. Severe exacerbations were defined as exacerbations requiring oral steroid treatment for at least three days, an emergency room visit, or hospitalisation. Patients in the Symbicort® adjustable dosing arm also used 27 per cent less short-acting bronchodilator as needed for symptom relief, an additional marker of asthma control compared with the two fixed dose groups. This increased control of exacerbations with Symbicort® adjustable maintenance dosing was achieved, whilst overall Symbicort® use was reduced, compared with a fixed dose of Symbicort® used in the same study.
The current worldwide market for fixed combination asthma products is estimated to be worth $3.5 billion. To date, Symbicort® is launched in over 45 markets and approved in 78 countries. 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, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
Media Enquiries:
Steve Brown, +44 (0) 207 304 5033
Edel McCaffrey, +44 (0) 207 304 5034
Investor Enquiries:
Mina Blair-Robinson, +44 207 304 5084
Jonathan Hunt, +44 207 304 5087
Notes to editors
European Union countries include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom.
Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally.
Most asthma patients require maintenance treatment with an inhaled corticosteroid, which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.
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