AstraZeneca drugs gets FDA approval
The US Food and Drug Administration (FDA) has given approval to AstraZeneca's SEROQUEL, the drugs company's treatment for bipolar I disorder.
The FDA has approved the drug for the treatment of schizophrenia. SEROQUEL is also 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, AstraZeneca said.
The approval follows two studies where the aim was to prove an increase in the interval between the occurrence of depressive, manic, or mixed mood events for those patients being treated with SEROQUEL plus lithium-or-divalproex.
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The studies indicated that patients treated with SEROQUEL plus lithium-or-divalproex.had a risk reduction of 70% to those treated with a placebo plus lithium-or-divalproex for time to recurrence of a mood event.
The proportion of patients who relapsed when treated with SEROQUEL was 19.3% versus 50.4% of patients on placebo.
AstraZeneca said around 8m Americans suffer from bipolar disorder, a condition more commonly known to the lay-person as manic depression.
