AZ submits sNDA for Seroquel to treat GAD

AstraZeneca, the Anglo-Swedish major drug major, has submitted a supplemental New Drug Application to the US Food and Drug Administration to extend the indication of its blockbuster Seroquel XR (quetiapine fumerate) extended-release tablets to treat generalized anxiety disorder, including maintenance of antianxiety effect.

The antipsychotic performed well in four Phase III studies. Three short-term, multicenter, randomized, placebo-controlled trials on outpatients with GAD, and one long-term, mutlicenter, randomized-withdrawal, parallel-group, placebo-controlled study. All showed Seroquel provided a greater symptom reduction versus placebo by the Hamilton Rating Scale and offered a consistent safety profile, the firm said.

Seroquel is currently approved as a schizophrenia treatment for adults and made global sales of $4.03 billion in 2007. This is the fourth supplemental application submitted by AZ for the drug in the last two years (Marketletters passim). The firm hopes its product will be approved for use in treating manic and depressive episodes in bipolar disorder, and as monotherapy, adjunct therapy and maintenance therapy for major depressive disorder. The FDA is currently reviewing all five of the applications.