Favorable Vote From FDA Advisory Committee on SEROQUEL Pediatric Supplemental New Drug Applications
11 June 2009 - 8:32AM
PR Newswire (US)
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.
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