AstraZeneca files sNDA for bipolar disease drug

Published: 1-Feb-2003
Regulatory


AstraZeneca (AZ) has submitted a Supplemental New Drug Application (sNDA) to the US FDA for Seroquel (quetiapine) for the treatment of acute mania associated with bipolar disorder.

The application follows the completion of a comprehensive bipolar disorder clinical trial programme undertaken by AZ to examine the efficacy and tolerability of Seroquel in this important disease area. The company says the programme has delivered consistently strong and positive results in both the monotherapy and adjunctive therapy studies.

The proposed new indication is expected to expand the market for Seroquel, which is currently indicated for the treatment of schizophrenia in adults.

Bipolar disorder affects an estimated 2.3m adults in the US alone and is estimated to constitute a multibillion-dollar market. To date, some 4m people worldwide have been treated with Seroquel, which is the fastest-growing atypical antipsychotic on the market.

The trial programme consisted of four studies involving approximately 1,000 patients in 28 countries. The results from one of the combination therapy studies showed that Seroquel, in combination with standard mood stabilising medication (lithium or divalproex), is significantly more effective at treating the manic symptoms of bipolar disorder than mood stabilisers alone.

Importantly, the results also showed that the drug is well tolerated – a major consideration in the treatment of this disorder. The results from the remaining monotherapy studies will be presented at major psychiatry conferences this year.

'We are very pleased with the results of the trial programme and are extremely optimistic about the future for Seroquel. It is a unique compound and its profile is ideal for the treatment of bipolar disorder,' commented Geoff Birkett, AstraZeneca global vice president, CNS, Pain and Infection.

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