AstraZeneca announced that the US Food and Drug Administration (FDA) has approved once-daily Seroquel XR (quetiapine fumarate) Extended Release tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD). Seroquel XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.

MDD affects approximately 14.2 million American adults in a given year, and today it is often treated with antidepressants. Selective serotonin reuptake inhibitors, or SSRIs, are among the most commonly prescribed class of antidepressant medications for depression; however, in many cases patients fail to respond adequately to treatment. Results from a National Institute of Mental Health study, STAR D, showed that approximately 63 per cent of patients did not achieve remission with the SSRI citalopram when used as a first-line treatment. Additionally, this study reported that overall approximately one-third of patients with MDD failed to achieve study defined remission. This approval for Seroquel XR provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant.

In addition to the FDA approval for the adjunctive indication in MDD, AstraZeneca has received a Complete Response Letter (CRL) from the FDA asking for additional information for the sNDAs for Seroquel XR as acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients.

AstraZeneca is evaluating the contents of the CRL. AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course. The CRL does not change the current recommendations for the treatment of patients taking Seroquel XR for approved indications in schizophrenia and bipolar disorder.

The FDA has required that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS). The REMS for Seroquel XR requires a Medication Guide and periodic assessments that will include a survey of patients' understanding of the potential risks of Seroquel XR. The REMS applies to all approved indications.

Seroquel XR is part of a class of drugs called atypical antipsychotics and is approved for a number of mental health disorders. In addition to today’s approval for the adjunctive treatment of MDD, Seroquel XR is currently approved for the acute and maintenance treatment of bipolar disorder and schizophrenia.