AstraZeneca Announces European SEROQUEL XR Submission

AstraZenecaAstraZeneca has announced its submission of SEROQUEL XR (quetiapine fumarate extended release tablets) to European regulatory authorities seeking approval for both short-term and maintenance treatment of Generalised Anxiety Disorder (GAD). This is the first time approval has been sought in Europe for an atypical antipsychotic medicine for the treatment of GAD.

The submission is based on a robust clinical development programme involving more than 3,500 patients in five Phase III efficacy and safety studies. Data from the programme were presented earlier this year at the 21st ECNP Congress in Barcelona in September and at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C. in May. In the data presented, significantly greater symptom improvements were seen in patients treated with quetiapine XR compared to those treated with placebo in short-term treatment, and quetiapine XR demonstrated a fast onset of action with improvement observed as early as day 4. This improvement was shown to be upheld during maintenance therapy. Quetiapine XR was generally well tolerated and the safety and tolerability were consistent with the known safety profile of quetiapine.

During their lifetimes, it is estimated between 2.7% and 5.4% of people in Europe will suffer from GAD. Characteristic symptoms include persistent anxiety, exaggerated worry and tension, and GAD is often accompanied by depression or other anxiety disorders. It also has a substantial negative impact on Health-Related Quality of Life (HRQoL), productivity at work (including absenteeism) and healthcare costs.

Antidepressants (SSRIs - selective-serotonin reuptake inhibitors and SNRIs – serotonin and norepinephrine reuptake inhibitors) are standard treatments for GAD that are generally effective, but approximately 30 percent of patients treated with SSRIs or SNRIs will have an inadequate response to short term treatment. Additionally, antidepressants may have a relatively slow onset of action (2–4 weeks), sometimes requiring combination with a short course of benzodiazepines (BZDs) to achieve initial symptom control; however, long term treatment with these agents is generally not recommended.

About Generalised Anxiety Disorder (GAD)
GAD is a syndrome of ongoing anxiety and worry that is typically recognised as excessive or inappropriate and lasts for at least 6 months. People with the condition are usually overly concerned about everyday matters and tend to anticipate disaster. Physical symptoms of the disorder include fatigue, headaches, muscle tension, muscle aches, difficulty swallowing, trembling, irritability, sleep disturbances, sweating and hot flushes.

About SEROQUEL and SEROQUEL XR
In May 2008, SEROQUEL XR (extended release quetiapine tablets) became the first antipsychotic to complete a clinical development programme and be filed with the FDA in the US seeking approval for the treatment of GAD. Today it is not approved in any country for the treatment of GAD but remains under review by the regulatory authorities in the US. A filing for SEROQUEL XR seeking approval for the treatment of Major Depressive Disorder was made in the US in February with the EU filing in June. SEROQUEL XR is not approved for these indications at this time and the applications remain under review by the regulatory authorities.

SEROQUEL XR is approved in 39 countries for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients, 10 countries for bipolar mania and 5 countries for bipolar depression. It was launched in the US in 2007 and earlier this month AstraZeneca announced the approval of SEROQUEL XR in the US for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.

Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide. It is approved in 92 countries for the treatment of schizophrenia, in 88 countries for the treatment of bipolar mania, and in 29 countries including the US for the treatment of bipolar depression.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information please visit www.astrazeneca.com.

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