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.
The data from the clinical studies of Seroquel XR reviewed by MEB have now been published. Professor Rene Kahn, Professor and Chair of the Department of Psychiatry and Head of the Division of Neuroscience at the University Medical Center, Utrecht, said: "In clinical studies Seroquel XR showed its potential as a once-daily treatment for both acute and clinically stable schizophrenia patients. In the clinical trials, the effective dose range was reached within two days of starting treatment - the data demonstrated that range is between 400 and 800 mg/day. In mental healthcare, striving for treatment that is simpler and more practical is an important objective for patients and doctors. The right treatment enables patients to begin a path to recovery - not only in mental and physical terms but in emotional and social terms also."
Beyond schizophrenia, ongoing clinical studies of Seroquel XR cover bipolar disorder, major depressive disorder and generalized anxiety disorder. Seroquel (original formulation quetiapine) is the number one prescribed atypical antipsychotic in the United States and global sales for Seroquel reached US$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 it was approved in the US by the FDA for the treatment of bipolar depression.