The FDA has approved AstraZeneca's once-daily Seroquel XR Extended Release Tablets as an adjunctive 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 MDD as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, according to AZ.
MDD affects approximately 14.2 million American adults in a given year, and is often treated with antidepressants. This approval 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 approval for the adjunctive indication in MDD, AZ 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.
AZ is evaluating the contents of the CRL and will continue discussions with the FDA and will provide a response to the agency. 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.