AstraZeneca submits EU MAA for Seroquel XR in MDD

Anglo-Swedish drug major AstraZeneca has submitted applications in the European Union for once-daily Seroquel XR (quetiapine fumarate) extended-release tablets, seeking approval for major depressive disorder including maintenance therapy in adult patients, using the Mutual Recognition Procedure. This follows a supplemental New Drug Application submission for the agent in MDD in the USA in February this year.

Data from eight randomized placebo-controlled studies of quetiapine XR at once-daily doses of 50mg, 150mg and 300mg in patients diagnosed with MDD support the submission, the firm noted. These include four short-term monotherapy studies involving 2,116 patients; two short-term adjunct therapy studies involving 939 subjects 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 people.

The short-term studies used the Montgomery-Asberg Depression Rating Scale 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 while 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.