AstraZeneca files Seroquel for GAD in Europe

Anglo-Swedish drug major AstraZeneca has submited Serooquel XR (quetiapine fumarate extended release tablets) to the European regulatory authorities seeking approval for both short-term and maintenance treatment of generalized anxiety disorder. Building on the US GAD submission announced in May, this is the first time approval has been sought in Europe for an atypical antipsychotic medicine for the treatment of GAD, the firm notes.

The submission is based on a robust clinical development program involving more than 3,500 patients. Data from this were presented earlier this year at the 21st ECNP Congress in Barcelona in September and at the 161st Annual Meeting of the American Psychiatric Association in Washington DC in May. In the data presented, significantly greater symptom improvements were seen in patients treated with quetiapine XR compared to those on placebo in short-term treatment, with improvement observed as early as day four. Symptom improvement was shown to be upheld during maintenance therapy. Quetiapine XR was generally well tolerated and the safety and tolerability were consistent with the known safety profile of quetiapine, according to the drug major.