FDA gives mixed review to Seroquel XR for treatment of MDD, GAD

WILMINGTON, Del. An advisory committee of the Food and Drug Administration has given a mixed review to an approval application by AstraZeneca seeking additional uses for one of its drugs as a treatment for major depressive disorder and generalized anxiety disorder.

The FDA Psychopharmacologic Drugs Advisory Committee concluded that Seroquel XR (quetiapine fumarate) extended-release tablets were shown to be effective as a standalone and adjunctive therapy for MDD, and as a standalone therapy for GAD, and to be acceptably safe as an adjunctive therapy for MDD. At the same time, however, the committee did not find it to be acceptably safe as a standalone therapy for GAD or as a standalone therapy for broad treatment for MDD, and remained undecided as to whether the drug was safe as a standalone therapy for MDD in other circumstances.

“We are pleased that the committee found Seroquel XR to be effective and acceptably safe for use as adjunctive therapy of MDD,” AstraZeneca chief medical officer Howard Hutchinson said. “Although the committee recognized the effectiveness of Seroquel XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations.”

The FDA usually takes advisory committees’ opinions into consideration when making a final decision about whether to approve a drug, but it is not required to follow it. Seroquel XR has approval for treating schizophrenia and bipolar disorder, but not MDD or GAD.