AstraZeneca has suffered a setback with the news that regulators in The Netherlands have rejected the firm’s bid to market the antipsychotic Seroquel XR for a certain type of depression.

The Anglo-Swedish drugmaker says it has been notified by the Netherlands Health Authority, acting as the reference member state for the European Union’s mutual recognition process, that the Seroquel XR (quetiapine) application for major depressive disorder has been refused. The Dutch regulator is not impressed with the drug’s risk-benefit profile for MDD so AstraZeneca is trying another tack.

The company has now referred its application to use the drug in MDD to the European Medicines Agency’s Committee for Medicinal Products for Human Use, thus seeking a central approval. Seroquel XR is currently approved for treating schizophrenia and bipolar disorder, and AstraZeneca noted that it has just been approved by Health Canada for MDD.

Across the Atlantic, the chances of getting an approval in this new indication look a bit more promising. Last month, the US Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee decreed that Seroquel XR 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 the treatment, an extended-release form of Seroquel, was shown to be acceptably safe in certain instances as a monotherapy for MDD. That stance was taken following the release of documents from FDA staffers who said there is “accumulating evidence" that the drug may have "substantial metabolic risk", such as weight gain and tardive dyskinesia.

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