AstraZeneca today 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 Seroquel XR 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. Seroquel XR 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 a severe mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self. 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 Seroquel XR evaluating effectiveness and safety at doses of 400, 600, and 800 mg/day, in acute treatment, relapse prevention and also in a non-inferiority study of acute efficacy and safety when switching from the original formulation to Seroquel XR.