AstraZeneca has announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.
With the product, patients can achieve a dose within the recommended range as early as the second day of treatment and the MEB approval also includes relapse prevention in the long-term treatment of schizophrenia. AstraZeneca will proceed with a Mutual Recognition Procedure, seeking similar approvals across Europe. The product was approved for the treatment of schizophrenia in the US in May 2007.
SEROQUEL XR™ has been developed with the aim of improving dosing and titration options for patients and their doctors as they face the challenge of achieving successful treatment of schizophrenia. World Health Organisation (WHO) statistics indicate that schizophrenia affects about 24 million people worldwide. It subjects people to social isolation, poor quality of life and increased mortality. It is estimated that SEROQUEL® (original formulation quetiapine) has been used to treat more than 19 million patients worldwide since its launch in 1997.
The MEB approval was based on clinical trials of the product evaluating effectiveness and safety at doses of 400, 600, and 800 mg/day, in acute treatment, relapse prevention and in a non-inferiority study of acute efficacy and safety when switching from the original formulation to SEROQUEL XR™.
Beyond schizophrenia, ongoing clinical studies of the product cover bipolar disorder, major depressive disorder and generalised anxiety disorder. SEROQUEL® (original formulation quetiapine) is the number one prescribed atypical antipsychotic in the United States and global sales for SEROQUEL® reached $3.4 billion in 2006. It is licensed in 85 countries for the treatment of schizophrenia, in 73 countries for the treatment of mania associated with bipolar disorder, and in October 2006, the FDA approved it for the treatment of bipolar depression in the US.
