AstraZeneca completes EU mutual recognition for Symbicort

AstraZeneca has revealed that it has “successfully completed” the European Union mutual recognition procedure for Symbicort maintenance and reliever therapy (Smart), allowing asthma patients to use their Symbicort inhaler for both maintenance and relief.

The UK’s second-largest pharmaceutical company claims that national approvals across the EU will follow in coming months for this new indication, based on the findings of a clinical trial programme involving 14,000 patients with mild to severe persistent asthma.

Last month, AstraZeneca released the details of several studies comparing Symbicort to Seretide, the GlaxoSmithKline rival. Symbicort was said to have reduced the risk of a severe asthma attack by a third and cut the total number of asthma attacks by 39 per cent, in comparison to Seretide.

Dr John Patterson, executive director for development at AstraZeneca, commented: “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,” he added.

Symbicort is currently AstraZeneca’s second best-selling respiratory drug, after Pulmicort. The company’s respiratory drugs brought in over $1.5 billion in sales revenues during the first half of 2006.