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FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
Date:4/8/2009

WILMINGTON, Del., April 8 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

The Advisory Committee concluded:

  • SEROQUEL XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy.
  • SEROQUEL XR was shown to be acceptably safe as an adjunctive treatment for MDD.
  • SEROQUEL XR was not shown to be acceptably safe as a monotherapy for broad treatment for MDD.
  • The committee was undecided as to whether SEROQUEL XR was shown to be acceptably safe in certain instances as a monotherapy treatment for MDD.
  • SEROQUEL XR was not shown to be acceptably safe as a monotherapy for the treatment of GAD.

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: "We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. Although the committee recognized the effectiveness of SEROQUEL XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations. We look forward to having further discussions with the FDA regarding both sNDAs."

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.

SEROQUEL XR is not approved for the treatment of MDD and GAD.

ABOUT SEROQUEL XR AND SEROQUEL

SEROQUEL XR, a once-daily, extended-release tablet formulation of SEROQUEL(R) (quetiapine fumarate) tablets, was approved in the U.S. in 2007 for the acute and maintenance treatment of schizophrenia in adult patients and in October 2008 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.

Important Safety Information for SEROQUEL XR and SEROQUEL

SEROQUEL XR is indicated for the treatment of acute depressive episodes associated with bipolar disorder, acute manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or divalproex; maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex, and acute and maintenance treatment of schizophrenia. 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; 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 XR and SEROQUEL are 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 XR and SEROQUEL are 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 quetiapine. 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 Greater Than or Equal To 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 Greater Than or Equal To 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 quetiapine. Rare cases of NMS have been reported with quetiapine. 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 quetiapine. 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 XR and 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 XR 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. Quetiapine 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 XR vs. placebo in clinical trials for schizophrenia and bipolar disorder were somnolence (25%-52% vs. 10%-13%), dry mouth (12%-37% vs. 1%-7%), constipation (6%-10% vs. 3%-6%), dyspepsia (5%-7% vs. 1%-4%), dizziness (10%-13% vs. 4%-11%), orthostatic hypotension (7% vs. 5%), weight gain (7% vs. 1%), increased appetite (12% vs. 6%), fatigue (6%-7% vs. 2%-4%), dysarthria (5% vs. 0%), and nasal congestion (5% vs. 1%). 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 XR and SEROQUEL.

About AstraZeneca

AstraZeneca (NYSE: AZN) 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 2007. Nothing contained herein should be construed as a profit forecast.

NOTES TO EDITORS:

    Questions to the Advisory Committee              Yes   No   Abstain
    1. Has SEROQUEL XR been shown to be effective
     as a treatment of:
    -- MDD as an adjunct therapy?                      9    1        0
    -- MDD as a monotherapy?                           8    1        1
    -- GAD as a monotherapy?                           7    2        1
    2. Has SEROQUEL XR been shown to be
     acceptably safe as an adjunctive treatment
     for MDD?                                          6    3        0
    3. Has SEROQUEL XR been shown to be
     acceptably safe as a treatment for:
    -- MDD as a monotherapy?                           0    9        0
    -- GAD as a monotherapy?                           0    9        0
    4. Has SEROQUEL XR been shown to be
     acceptably safe in certain instances as a
     treatment:
    -- MDD as a monotherapy?                           4    4        1
    -- GAD as a monotherapy?                           2    6        1

In due course the full vote will be available on the FDA web site.


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SOURCE AstraZeneca
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