FDA AdCom recommendation on S

RNS Number : 7185T

AstraZeneca PLC

11 June 2009

 



FAVOURABLE VOTE FROM FDA ADVISORY COMMITTEE ON SEROQUEL PAEDIATRIC SUPPLEMENTAL NEW

DRUG APPLICATIONS

On 10 June 2009, 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) 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 paediatric patients ages 13-17?	17	1	0
2. Has Seroquel been shown to be acceptably safe for the treatment of schizophrenia in paediatric patients ages 13-17?	16	0	2
3. Has Seroquel been shown to be effective for the treatment of bipolar mania in paediatric patients ages 10-17?	17	0	1
4. Has Seroquel been shown to be acceptably safe for the treatment of bipolar mania in paediatric 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.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com

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11 June 2009

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