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Biopharmaceuticals Regulatory

 News Release - September 28, 2010

AstraZeneca UK Receives Positive Decision For Seroquel XL(R)[Black Triangle Drug] (Quetiapine Prolonged Release) as an Add-On Treatment of Major Depressive Disorder

Quetiapine Prolonged Release Becomes the Only Atypical Antipsychotic Approved for Major Depressive Disorder (MDD) as Adjunctive Therapy, and as Monotherapy for Acute Depressive Episodes Associated With Bipolar disorder.

LONDON, September 28, 2010 -- (Healthcare Sales & Marketing Network) -- AstraZeneca UK is delighted to announce that it has today received UK approval for Seroquel XL(R)[Black Triangle Drug] (quetiapine prolonged release) as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Prior to initiating treatment, clinicians should consider the safety profile of quetiapine prolonged release. The decision follows the European Commission approval earlier this month.

According to the Depression Alliance one in five people will have depression at some point in their life[1], and MDD is the leading cause of suicide particularly in people who have not received adequate treatment for their symptoms[2]. As up to 50% of people who suffer from MDD do not respond to first-line antidepressant treatment[3], add-on treatments are regularly used to manage this serious condition and are included in national guidelines[4],[5]. The new indication for quetiapine prolonged release will therefore potentially benefit such people who have failed to respond to first-line treatment and who require additional therapy.

"Depression is an important public-health problem which has been shown to have a greater negative effect on health than angina, arthritis, asthma, and diabetes,"[6] said Stuart Montgomery, Emeritus Professor of Psychiatry. "Effective medicines are a cornerstone of management for people with depression, and this new indication for quetiapine prolonged release provides healthcare professionals with a new option of add-on therapy when considering how best to treat inadequately responding MDD. This can only be good news for people who suffer from this serious and common condition."

According to a recent report from the mental health charity Rethink, 'Fair Treatment Now' launched in July 2010, mental illness costs us all around GBP33.75 billion each year, but less than a quarter of this is spent on providing health services. Most of it is channelled into other public services which are needed to pick up the pieces when things go wrong.[7] Further treatment options that have the potential to treat people with mental health conditions may therefore help to reduce the overall cost of mental health issues to society, as well as improving the lives of individual patients.[7]

Mark Jones, Marketing Company President at AstraZeneca UK, said, "We at AstraZeneca UK are delighted that Seroquel XL has received this licence for MDD, as this means that people who haven't had their symptoms fully controlled after initial therapy have a new add-on treatment option available for their physicians to consider. The licence also further establishes the antidepressant efficacy of Seroquel XL following its approval for depressive episodes in people with bipolar disorder."

Along with the update to the licenced indications, the Summary of Product Characteristics for quetiapine prolonged release has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of quetiapine prolonged release, including consideration of the safety profile with respect to the individual patient's diagnosis and the dose being administered. Prior to initiating treatment, clinicians should consider the safety profile of quetiapine prolonged release.

Notes to editors

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit:

About Seroquel XL(R)[Black Triangle Drug] (quetiapine prolonged release)

Seroquel XL(R)[Black Triangle Drug] (quetiapine prolonged release) is an atypical antipsychotic medication[8] indicated for the treatment of:

Schizophrenia including:

- Preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XL

Bipolar disorder including:

- Manic episodes associated with bipolar disorder

- Major depressive episodes in bipolar disorder

- Preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.

Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Prior to initiating treatment, clinicians should consider the safety profile of Seroquel XL

For more information please refer to the Summary of Product Characteristics.


[1] Depression Alliance. One in five factsheet. Available online at: Last accessed 07 September 2010

[2] Rihmer Z, Kiss K. Bipolar Disorders 2002; 4 (Suppl. 1): 21-25

[3] Fleurence R et al. A Systematic Review of Augmentation Strategies for Patients with Major Depressive Disorder. Psychopharmacology bulletin. 2009;42:3:57

[4] Anderson I et al. Evidence-based guidelines for treating depressive disorders with antidepressants: A revision of the 2000 British Association for Psychopharmacology guidelines. Journal of Psychopharmacology 2008: 22: 343-396

[5] National Institute for Health and Clinical Excellence. Depression, Clinical Guideline 90. October 2009

[6] MousSAVI S et al. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet 2007; 370: 851-58

[7] Fair Treatment Now - Campaign report. Rethink July 2010

[8] Seroquel XL. Summary of Product Characteristics. Available online at:

Source: AstraZeneca UK

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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