Friday, 4 December 2009
AstraZeneca today announced that the US Food and Drug Administration (FDA) approved SEROQUEL (quetiapine fumarate) Tablets for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex.
The SEROQUEL paediatric clinical programme was undertaken to provide important clinical information for healthcare providers who treat paediatric patients with the serious diseases schizophrenia and bipolar mania. The paediatric studies for SEROQUEL were designed and initiated in consultation with FDA in accordance with a formal Written Request, pursuant to Section 505A of the Federal Food, Drug, and Cosmetic Act, for paediatric information on SEROQUEL.
“Bipolar mania and schizophrenia in children and adolescents, while rare, are serious disorders and it is important to have treatments approved for use in this patient population,” said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca. “Because individuals respond differently to medications, patients and practitioners need proven treatment options that permit them to weigh safety and efficacy in individual circumstances. These new indications for SEROQUEL provide another FDA-approved option for treating paediatric patients suffering from these severe mental illnesses.”
The SEROQUEL paediatric approval is based on data from four studies. Three of the studies (Study 112, Study 149, and Study 150) evaluated the efficacy and safety of SEROQUEL in the treatment of adolescents with schizophrenia (13-17 years of age) or children and adolescents with bipolar I disorder (10-17 years of age). The fourth study (Study 28) assessed the pharmacokinetic profile of SEROQUEL in children and adolescents. Doses of 400 mg to 800 mg of SEROQUEL were specifically studied in the paediatric program.
The FDA has required that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS). The REMS for SEROQUEL requires a Medication Guide and periodic assessments that will include a survey of patients' understanding of the potential risks of SEROQUEL. The REMS applies to all approved indications.
NOTES TO EDITORS:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com
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