Committee approves limited use of Seroquel in depression
pharmafile | April 9, 2009 | News story | Research and Development, Sales and Marketing |Â Â AZ, Seroquel, USÂ
An FDA advisory committee has concluded that safety concerns mean that Seroquel XR should not be used to treat anxiety, but can be used in depression.
The Psychopharmacologic Drugs Advisory Committee ruled that the drug could be used as an adjunctive treatment in major depressive disorder (MDD), but rejected its use as a monotherapy in depression or in generalised anxiety disorder (GAD).
The decision is mixed news for AstraZeneca, which is likely gain a licence to extend the use of Seroquel, but not as widely as it had hoped.
Seroquel XR is already a leading treatment for schizophrenia and bipolar disorder, and earned $4.4 billion revenues last year.
The committee ruled that side effects, including a relatively rare but potentially fatal condition should mean the drug should not be widely used to treat major depressive disorder (MDD) and generalised anxiety disorder (GAD).
Raised blood sugar levels, increased cholesterol levels and weight gain were all observed in a significant number of patients taking the drug (compared to placebo), persuading the experts the drug's benefits were outweighed by its risks.
A number of more rare but more serious side effects observed in patients also raised concerns.
A potentially fatal symptom complex, neuroleptic malignant syndrome (NMS) was seen in a small number of patients as were leukopenia, neutropenia, and agranulocytosis and tardive dyskinesia (TD).
The nine members of the committee were unanimous in concluding that the drug was not safe as a monotherapy in either condition.
But opinions were divided about whether or not it could be used in certain circumstances for MDD – four committee members voted in favour of approving it, while four opposed it and one abstained.
AstraZeneca could choose to try again to gain a limited indication for the drug to treat MDD as a monotherapy.
Howard Hutchinson, chief medical officer at 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 recognised 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."
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