AstraZeneca submits Seroquel for FDA approval

AstraZeneca filed an application to the US Food and Drug Administration (FDA) to gain approval of its drug Seroquel, which will make the drug a world first.

Seroquel is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia, but the company is now seeking approval for its use for treating patients with depressive episodes associated with bipolar disorder.

Dr Wayne Macfadden, US medical director for Seroquel, said: “AstraZeneca is dedicated to improving patients’ lives and developing new treatments for mental illness.

“This sNDA [supplemental New Drug Application] submission is an important milestone in the history of Seroquel.

“If Seroquel receives approval from the FDA to treat bipolar depression, it would be the only single agent indicated to treat both the depressive and manic episodes associated with bipolar disorder.”

The sNDA submission has been based on research that found patients receiving Seroquel showed a statistically significant decrease in depression after one week and a reduction in depression throughout the eight-week study.

More than half of the Seroquel treated patients in each trial met the criteria for remission.

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