AstraZeneca Successfully Completes Mutual Recognition Procedure For Symbicort Maintenance And Reliever Therapy Symbicort SMART) in the EU

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

Symbicort SMART is licensed for use in adults who need an inhaled corticosteroid (ICS) and a long acting bronchodilator (LABA) combination treatment. National approvals are expected to be issued throughout the EU over the coming months.

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. With Symbicort SMART, patients take a maintenance dose of Symbicort to keep control of their asthma and if further symptoms occur, can take additional inhalations ‘as needed’, to provide symptom relief. When compared to traditional gold standard therapy, using multiple separate inhaler devices, Symbicort SMART is a more effective way to manage asthma, as it provides a simple way for patients to improve daily symptom control and reduce the risk of asthma attacks.

Dr John Patterson, Executive Director, Development for AstraZeneca said, “This new treatment approach has the potential to improve the lives of many patients with asthma in Europe. By reducing both symptoms and the number of attacks they experience, patients can now achieve excellent asthma control using only one inhaler rather than the traditional approach of using multiple inhalers.”

Symbicort SMART has been studied in a wide clinical trial programme 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.

This extensive clinical trial programme includes COMPASS, 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 with 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 percent and to significantly reduce the total number of severe asthma attacks by 39 percent. 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 study, 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 and in July 2006 received US Food and Drug Administration (FDA) approval for maintenance treatment of asthma. Symbicort SMART is already approved in Argentina, Australia, Brazil, Mexico, the Philippines, Switzerland and Thailand. Symbicort has reached more than 5 million patient years, with sales reaching $585 million in the first half of 2006.

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 Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

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