AstraZeneca Submits Seroquel XR™ in Europe for the Treatment of Major Depressive Disorder

AstraZeneca today announced that the company has submitted applications in the European Union (EU) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets (quetiapine XR), seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy in adult patients using the Mutual Recognition Procedure (MRP). This follows a supplementary New Drug Application (sNDA) submission for SEROQUEL XR in MDD in the U.S. in February this year.
Each year, around 33 million people will suffer from MDD in Europe - between three and ten per cent of the population. Today, it is treated with generic or branded antidepressants, including SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors). Studies have shown at least one-third of patients fail to achieve a satisfactory response with current antidepressant therapy. SEROQUEL XR is the first atypical antipsychotic medicine to be submitted in Europe for approval for the treatment of MDD. AstraZeneca has investigated its use in MDD as a potential new treatment option for patients who do not respond adequately to current treatments.

Data from eight randomised placebo-controlled studies of quetiapine XR at once-daily doses of 50, 150 and 300 mg in patients diagnosed with MDD support the submission announced today. These include four short-term monotherapy studies involving 2116 patients; two short-term adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to prior antidepressant therapy; a longer-term monotherapy maintenance study involving 1,854 patients and up to 78 weeks of treatment; and a further short-term study involving 338 elderly patients. The short-term studies used the Montgomery-Åsberg Depression Rating Scale (MADRS) as the primary assessment of depression symptoms and the longer-term study assessed time-to-a-depressed-event using criteria including MADRS as the primary endpoint. The short-term studies demonstrated that quetiapine XR reduced depressive symptoms by week one whilst the long-term study demonstrated that efficacy was maintained. The safety and tolerability of quetiapine XR was consistent with the known safety profile of quetiapine.

AstraZeneca’s clinical development programme for quetiapine XR includes studies in Generalised Anxiety Disorder (GAD) and a European submission for that indication is planned for the second half of 2008.