AZ files sNDA for bipolar disease drug
AstraZeneca (AZ) has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Seroquel (quetiapine) for the treatment of acute mania associated with bipolar disorder (manic depressive illness).
The application to the FDA 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 programme has delivered consistently strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm Seroquel to be an ideal first line agent.
'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, global vice president, CNS, Pain and Infection.
The proposed new indication is expected to expand the market for Seroquel, which is currently indicated for the treatment of schizophrenia in adults.
Analysts estimate that bipolar disorder alone constitutes a multibillion-dollar market. The illness affects an estimated 2.3m American adults and is ranked as the second leading cause of disability worldwide among the neuropsychiatric disorders. To date, over four million people have been treated with Seroquel worldwide, which is the fastest-growing atypical antipsychotic on the market, with annualised sales that approached US$1bn (Euro 0.95bn) in the third quarter of 2002.
The trial programme consisted of four studies involving approximately 1000 patients in 28 countries. The results from one of the combination therapy studies were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany. The results from this trial showed that Seroquel, in combination with standard mood stabilizing medication (lithium or divalproex), is significantly more effective at treating the manic symptoms of bipolar disorder than mood stabilizers 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 in 2003.