ASTRAZENECA FILES FOR SEROQUEL SR IN EUROPE, CANADA

AstraZeneca has submitted filings to European and Canadian authorities for the approval of the sustained-release (SR) once-daily formulation of Seroquel for the treatment of patients with schizophrenia. The submission will cover all markets in the EU where the drug is currently approved.

This follows a new drug application for Seroquel SR submitted in the U.S. earlier this year. The clinical development program supporting the application in the EU included trials using a titration period aimed at achieving a therapeutically effective dose by the second day of treatment. Another trial studied schizophrenia relapse prevention in long-term treatment with Seroquel SR. The SR formulation has patent protection until 2017.

Seroquel (quetiapine fumarate) has a well-established safety and efficacy profile, and it is estimated that more than 19 million people have been treated with the drug worldwide. Seroquel has been licensed for the treatment of schizophrenia since 1997 and it is available in 85 countries. The drug is also licensed in 73 countries for the treatment of mania associated with bipolar disorder. Seroquel is the No. 1 prescribed atypical antipsychotic in the United States, with global sales of almost $2.8 billion in 2005, according to AstraZeneca.