Asthma :: Mutual recognition procedure for Symbicort maintenance n reliever therapy Symbicort smart

AstraZeneca announced that it has successfully completed the European Union Mutual Recognition Procedure (MRP) for Symbicort? Maintenance And Reliever Therapy (Symbicort SMART?). This new asthma treatment approach allows patients to use just one inhaler for both maintenance and relief of asthma symptoms.

Symbicort SMART is licensed for use in adults with a need for ICS/LABA combination treatment. National approvals are expected to be issued throughout the EU over the coming months.

With Symbicort SMART, the underlying inflammation is treated with every inhalation, making it a more effective treatment than traditional gold standard therapy, improving daily symptom control and reducing asthma attacks. The Symbicort SMART treatment approach is possible only because Symbicort combines the two components budesonide, an inhaled corticosteroid (ICS) providing anti-inflammatory effect, and formoterol, a unique bronchodilator (LABA) that is both rapid and long lasting, in one inhaler. Patients on Symbicort SMART receive a maintenance dose of Symbicort in line with normal practice to establish asthma control and take additional inhalations ?as needed’ of Symbicort if symptoms occur, to provide both rapid symptom relief and increased asthma control. A separate short-acting bronchodilator is no longer needed.

Dr John Patterson, Executive Director, Development for AstraZeneca said, ‘We are pleased that the mutual recognition procedure for Symbicort SMART has been successfully completed as this new treatment approach has the potential to improve the lives of a great many asthma patients in Europe. By reducing both symptoms and the number of attacks they experience, patients can now achieve excellent asthma control using only one inhaler.’

Symbicort SMART has been tested in a wide clinical trial program involving over 14,000 patients with mild to severe persistent asthma. These studies consistently show that Symbicort SMART, irrespective of asthma severity, reduces the risk of patients developing potentially life-threatening asthma attacks significantly better than fixed dosing with either higher doses of ICS alone or with an ICS/LABA combination therapy plus a short-acting bronchodilator. 1,2,3,4,5,6

This extensive clinical trial programme includes COMPASS1, a large, double-blinded, head-to-head study involving 3,335 patients with moderate to severe asthma, comparing Symbicort SMART to a double maintenance dose of Symbicort and a similar dose of Seretide? (fluticasone/salmeterol). When compared to Seretide, Symbicort SMART was shown to reduce the risk of a severe asthma attack (primary endpoint) by 33 per cent and to significantly reduce the total number of severe asthma attacks by 39 per cent. Similar effects were reported with Symbicort SMART when compared to double the maintenance dose of Symbicort. Symbicort SMART patients had equal levels of daily asthma control compared to both fixed dose treatment approaches, yet received a lower overall steroid load during the six-month study period. No differences were seen in the safety of these treatment approaches.

Further data from the SMILE study2, recently published in The Lancet, showed for the first time a positive effect of giving an inhaled steroid for daily maintenance and as-needed, i.e. to both prevent and treat symptoms. SMILE evaluated the benefits of different as needed therapies: budesonide/formoterol, formoterol or terbutaline on top of Symbicort maintenance therapy, in preventing asthma attacks. The use of as-needed budesonide/formoterol provided increased protection from severe attacks compared with terbutaline as-needed on top of Symbicort maintenance therapy. In addition, the use of budesonide/formoterol as-needed was significantly more effective than formoterol as-needed on top of Symbicort maintenance therapy.

Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years.

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 world’s leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index.

— Symbicort SMART is previously approved in Argentina, Australia, Brazil, Mexico, the Philippines, Switzerland and Thailand.

— Symbicort SMART is a new approach to managing asthma. Symbicort SMART is Symbicort used for both maintenance and symptom relief. With Symbicort SMART, the underlying inflammation is treated with every inhalation, making it a more effective way to manage asthma. No separate short-acting bronchodilator is no longer needed

— Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma.

— 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.

References: 1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006. 2. Rabe K, Atienza T, Magyar P et al. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53. 3. Vogelmeier C, D’Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828. 4. O’Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, Ekstr?m T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136. 5. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18. 6. Klaus F. Rabe, Emilio Pizzichini, Bj?rn St?llberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 – 256.

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