AstraZeneca today announced further submissions to Regulatory Authorities for the approval of the sustained release (SR) once-daily formulation of SEROQUEL? for the treatment of patients with schizophrenia, including Canada and a Marketing Authorisation Application (MAA) in the European Union (EU) under Mutual Recognition Procedure (MRP). The submission will cover all markets in the EU where SEROQUEL? is currently approved.
This follows the NDA for SEROQUEL SR? submitted in the US earlier this year. The clinical development programme supporting the SEROQUEL SR? 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 to 2017.
SEROQUEL? (quetiapine fumarate) has a well-established safety and efficacy profile and to date it is estimated that over 19 million people have been treated worldwide. SEROQUEL? has been licensed for the treatment of schizophrenia since 1997 and it is available in 85 countries for the treatment of this condition. SEROQUEL? is also licensed in 73 countries for the treatment of mania associated with bipolar disorder. SEROQUEL? is the number one prescribed atypical antipsychotic in the United States, with global sales of almost $2.8 billion in 2005.