A US advisory panel has handed out a qualified recommendation for AstraZeneca’s antipsychotic Seroquel XR and the firm’s bid to see the drug’s label expanded for certain types of depression.

The US Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee made its recommendations on the extended-release form of Seroquel (quetiapine) as a potential treatment of major depressive disorder (MDD) and generalised anxiety disorder (GAD). The panellists decreed that Seroquel XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and in GAD as monotherapy.

The PDAC added that the drug is “acceptably safe” as an adjunctive treatment for MDD, but not as a monotherapy for broad treatment for the disorder. The committee was undecided as to whether Seroquel XR was shown to be acceptably safe in certain instances as a monotherapy for MDD.

As for GAD, however, Seroquel XR was not shown to be acceptably safe as a monotherapy. The consensus among panellists was that there could be a role for the drug, which is currently indicated for schizophrenia and bipolar disorder, as a second-line therapy. The panel’s verdict followed the release of documents earlier this week from FDA staffers who said there is “accumulating evidence" that the drug may have "substantial metabolic risk", such as weight gain and tardive dyskinesia.

Howard Hutchinson, AstraZeneca’s chief medical officer, said the firm is pleased that the committee found Seroquel XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. He added that “we look forward to having further discussions with the FDA regarding both supplemental New Drug Applications”.

Seroquel is AstraZeneca's second-best-selling drug and had sales of $4.5 billion in 2008.