Favorable Vote From FDA Advisory Committee on SEROQUEL Pediatric Supplemental New...

Favorable Vote From FDA Advisory Committee on SEROQUEL Pediatric Supplemental
New Drug Applications

WILMINGTON, Del., June 10 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration (FDA) Psychopharmacologic Drugs Advisory Committee conducted a
review of the efficacy and safety of supplemental new drug applications
(sNDAs) for SEROQUEL (quetiapine fumarate) tablets proposed for the acute
treatment of schizophrenia in adolescents (13-17 years of age), and the acute
treatment of bipolar mania in children and adolescents (10-17 years of age).
The Advisory Committee voted as follows:

Questions to the Advisory Committee Yes No Abstain
1. Has Seroquel been shown to be effective
for the treatment of schizophrenia in
pediatric patients ages 13-17? 17 1 0
2. Has Seroquel been shown to be acceptably
safe for the treatment of schizophrenia in
pediatric patients ages 13-17? 16 0 2
3. Has Seroquel been shown to be effective
for the treatment of bipolar mania in
pediatric patients ages 10-17? 17 0 1
4. Has Seroquel been shown to be acceptably
safe for the treatment of bipolar mania
in pediatric patients ages 10-17? 13 0 5

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: "We are
pleased that the committee found SEROQUEL to be effective and acceptably safe
for treating adolescents with schizophrenia and children and adolescents with
bipolar mania, and we look forward to having further discussions with the FDA
regarding the sNDAs."

The current approved indications for SEROQUEL are unchanged. SEROQUEL is not
approved for use in patients under the age of 18 in any country.

The FDA frequently convenes advisory committee meetings to obtain independent
expert guidance and recommendations on clinical matters. While the FDA is not
required to follow this guidance, the agency usually takes the advice into
consideration when rendering its final decisions on pending applications and
other public health matters.

ABOUT SEROQUEL
SEROQUEL was first approved in the US in 1997 and is currently approved for
adults in the treatment of depressive episodes in bipolar disorder; acute
manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy
to lithium or divalproex; for the maintenance treatment of bipolar I disorder
as adjunct therapy to lithium or divalproex; and for the treatment of
schizophrenia. The safety of SEROQUEL has been evaluated in clinical trials
with thousands of adult patients and continues to be reviewed by the FDA.

Important Safety Information for SEROQUEL
SEROQUEL is indicated for the treatment of depressive episodes in bipolar
disorder; acute manic episodes in bipolar I disorder, as either monotherapy or
adjunct therapy to lithium or divalproex; for the maintenance treatment of
bipolar I disorder as adjunct therapy to lithium or divalproex; and
schizophrenia. Patients should be periodically reassessed to determine the
need for continued treatment and the appropriate dose.

Elderly patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death,
compared to placebo (4.5% vs. 2.6%, respectively). SEROQUEL is not approved
for the treatment of patients with dementia-related psychosis. (See Boxed
Warning.)

Antidepressants increased the risk of suicidal thinking and behavior in
children, adolescents, and young adults in short-term studies of major
depressive disorder and other psychiatric disorders. Patients of all ages
started on therapy should be observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should
be advised of the need for close observation and communication with the
prescriber. SEROQUEL is not approved for use in patients under the age of 18
years. (See Boxed Warning.)

Hyperglycemia, in some cases extreme and associated with ketoacidosis,
hyperosmolar coma, or death, has been reported in patients treated with
atypical antipsychotics, including SEROQUEL. The relationship of atypical use
and glucose abnormalities is complicated by the possibility of increased risk
of diabetes in the schizophrenic population and the increasing incidence of
diabetes in the general population. However, epidemiological studies suggest
an increased risk of treatment-emergent, hyperglycemia-related adverse
reactions in patients treated with atypical antipsychotics. Patients starting
treatment with atypical antipsychotics who have or are at risk for diabetes
should undergo fasting blood glucose testing at the beginning of and
periodically during treatment. Patients who develop symptoms of hyperglycemia
should also undergo fasting blood glucose testing.

In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose >/=
126 mg/dL) was observed in 10.7% of patients receiving quetiapine (mean
exposure 213 days) vs.4.6% in patients receiving placebo (mean exposure 152
days).
Clinically significant increases in cholesterol (7%-16% for quetiapine vs.
3%-9% for placebo) and triglycerides (8%-23% for quetiapine vs. 5%-16% for
placebo) have been observed in clinical trials.

The proportion of patients in clinical trials meeting a weight gain criterion
of >/= 7% of body weight was 5%-23% for quetiapine vs. 0%-7% for placebo.

A potentially fatal symptom complex, sometimes referred to as Neuroleptic
Malignant Syndrome (NMS), has been reported in association with administration
of antipsychotic drugs, including SEROQUEL. Rare cases of NMS have been
reported with SEROQUEL. Clinical manifestations of NMS are hyperpyrexia,
muscle rigidity, altered mental status, and evidence of autonomic instability
(irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac
dysrhythmia). Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure. The management of
NMS should include immediate discontinuation of antipsychotic drugs.

Leukopenia, neutropenia, and agranulocytosis (including fatal cases), have
been reported temporally related to atypical antipsychotics, including
SEROQUEL. Patients with a pre-existing low white blood cell (WBC) count or a
history of drug induced leukopenia/neutropenia should have their complete
blood count monitored frequently during the first few months of therapy. In
these patients, SEROQUEL should be discontinued at the first sign of a decline
in WBC absent other causative factors. Patients with neutropenia should be
carefully monitored, and SEROQUEL should be discontinued in any patient if the
absolute neutrophil count is 1000/mm3.

Tardive dyskinesia (TD), a potentially irreversible syndrome of involuntary
dyskinetic movements, may develop in patients treated with antipsychotic
drugs. The risk of developing TD and the likelihood that it will become
irreversible are believed to increase as the duration of treatment and total
cumulative dose of antipsychotic drugs administered to the patient increase.
TD may remit, partially or completely, if antipsychotic treatment is
withdrawn. SEROQUEL should be prescribed in a manner that is most likely to
minimize the occurrence of TD.

Warnings and Precautions also include the risk of orthostatic hypotension,
cataracts, seizures, hyperprolactinemia, and possibility of suicide attempts.
Examination of the lens by methods adequate to detect cataract formation, such
as slit lamp exam or other appropriately sensitive methods, is recommended at
initiation of treatment or shortly thereafter, and at 6-month intervals during
chronic treatment. The possibility of a suicide attempt is inherent in
schizophrenia, and close supervision of high risk patients should accompany
drug therapy.

The most commonly reported adverse reactions associated with the use of
SEROQUEL vs. placebo in clinical trials for schizophrenia and bipolar disorder
were somnolence (18%-57% vs. 8%-15%), dry mouth (9%-44% vs. 3%-13%), dizziness
(9%-18% vs. 5%-7%), constipation (8%-10% vs. 3%-5%), asthenia (5%-10% vs.
3%-4%), abdominal pain (4%-7% vs. 1%-3%), postural hypotension (4%-7% vs.
1%-2%), pharyngitis (4%-6% vs. 3%), weight gain (5%-6% vs. 1%-3%), lethargy
(5% vs. 2%), nasal congestion (5% vs. 3%), SGPT increased (5% vs. 1%), and
dyspepsia (5%-7% vs. 1%-4%).

Please see Prescribing Information, including Boxed Warnings for SEROQUEL.

About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and
marketing of meaningful prescription medicines and in the supply of healthcare
services. AstraZeneca is one of the world's leading pharmaceutical companies
with global healthcare sales of $ 31.6 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infectious disease medicines. In the United States, AstraZeneca is a $13.5
billion dollar healthcare business. For more information about AstraZeneca in
the US or our AZ&Me Prescription Savings programs, please visit:
www.astrazeneca-us.com.

The statements contain herein include forward-looking statements. Although we
believe our expectations are based on reasonable assumptions, any
forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual
outcomes and results to be materially different from those predicted. The
forward-looking statements reflect knowledge and information available at the
date of the preparation of this press release and the Company undertakes no
obligation to update these forward-looking statements. Important factors that
could cause actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond our control, include,
among other things, those risk factors identified in the Company's Annual
Report/Form 20-F for 2008. Nothing contained herein should be construed as a
profit forecast.

SOURCE AstraZeneca

Kirsten Evraire, +1-302-885-0435, kirsten.evraire@astrazeneca.com, or Abigail
Baron, +1-302-885-3578, abigail.baron@astrazeneca.com, both of AstraZeneca