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

By Astrazeneca Uk, PRNE
Monday, September 27, 2010

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 - 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: www.astrazeneca.co.uk

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.

    References

    ---------------------------------

    [1] Depression Alliance. One in five factsheet. Available online at:
        www.depressionalliance.org/publications/da_one_in_five.pdf.
        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:
        www.medicines.org.uk/emc/

For all UK healthcare and political correspondents: Isabelle Jouin, AstraZeneca +44(0)1582-836-077 or Richard Buchanan Brown, Red Door Communications +44(0)20-8392-8040.

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