AstraZeneca’s Seroquel wins approval from FDA

Source: Exec

Date :15/05/2008 13:37:21

AstraZeneca, the Anglo-Swedish pharmaceuticals giant, today announced that the US Food and Drug Administration approved Seroquel for the treatment of bipolar I disorder.

The drug can also be used for the treatment of schizophrenia, and is the only single agent approved by the FDA for the treatment of both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder.

Clinical trials

Bipolar disorder is considered one of the most severe forms of mental illness, and currently affects eight million adults in the US. It is a lifelong psychiatric condition characterised by manic or mixed mood episodes, interspersed with episodes of major depression.

The approval was based on two multicentre, randomised, double-blind, placebo-controlled clinical trials that evaluated Seroquel when used as an adjunct therapy to lithium or divalproex.

The study included a 12 to 36 week stabilisation phase, which was followed by up to two years of randomised double-blind treatment.

Results indicated that patients treated with Seroquel plus lithium or divalproex had a risk reduction of 70 percent. This risk reduction was significant for both recurrence of manic episodes, and recurrence of depressive episodes.

May 15, 2008