Successful MRP for AZ's Symbicort Turbohaler

Astrazeneca's Symbicort Turbohaler has successfully completed the mutual recognition procedure (MRP) in the EU for use in the maintenance therapy of chronic obstructive pulmonary disease (COPD) in patients with severe COPD and a history of exacerbations. Sweden acted as the reference member state. Symbicort is already a leading therapy in the treatment of asthma, and is now set to gain European approval as a combined β2-agonist and inhaled corticosteroid treatment for COPD.

'Symbicort will provide physicians with an effective and convenient treatment option for the long-term treatment of COPD,' said Dr Anders Ekblom, vp and head of the respiratory and inflammation therapy area, AZ. 'Patients with COPD stand to benefit from a substantially reduced risk of exacerbations, which are a major cause of medical intervention (including hospitalisations) and patient distress. Symbicort provides clinically meaningful benefits and, therefore, has the potential for reducing the burden of the disease.'

MRP application

AZ has also submitted an application to the 14 European Member States involved in the MRP for Seroquel (quetiapine) to be granted a licence for the treatment of manic episodes associated with bipolar disorder (manic-depressive illness).

The application to the European Health Authorities follows the completion of a comprehensive bipolar disorder clinical trial programme undertaken by AZ to examine the efficacy and tolerability of Seroquel. The programme has delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm Seroquel to be an ideal first line agent.

'We are delighted to submit our application to the European Health Authorities so soon after our submission to the FDA,' commented Geoff Birkett, global vp, CNS, Pain and Infection. 'Seroquel is a unique compound and its profile is ideal for the treatment of manic episodes associated with bipolar disorder. Use of it has been growing at a tremendous rate in Europe and feedback from patients and clinicians continues to be very positive. With its expanded indication range, we are sure of continued growth in 2003 and beyond.'

The proposed new indication is expected to expand the market for Seroquel, which is currently indicated for the treatment of schizophrenia in adults. Analysts estimate that bipolar disorder alone constitutes a multibillion-dollar market. The illness affects over 2% of the population worldwide and is also ranked as the second leading cause of disability worldwide among the neuro-psychiatric disorders. To date, over 4m people have been treated with Seroquel worldwide.

The trial programme consisted of four studies involving approximately 1000 patients in 28 countries. The results from one of the combination therapy studies were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany. The results from this trial showed that Seroquel, in combination with standard mood stabilizing medication (lithium or divalproex), is significantly more effective at treating the manic symptoms of bipolar disorder than mood stabilizers alone. Importantly, the results also showed that Seroquel is well tolerated – a major consideration in the treatment of this disorder. The results from the remaining monotherapy studies will be presented at major psychiatry conferences in 2003.