An FDA advisory panel voted unanimously Wednesday that AstraZeneca’s Seroquel XR (quetiapine) was not safe enough for use as monotherapy in treating major depressive disorder (MDD), but members supported use of the antipsychotic drug as an add-on therapy for patients who are not responding to current treatments. The drug was rejected by the committee as a treatment for generalised anxiety disorder (GAD).

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The panel’s chairman, Wayne Goodman, commented that in comparison to older drugs, he saw “no clear advantage demonstrated in [Seroquel XR's] efficacy…There were side-effects, and I would expect unintended consequences associated with wide-scale use of the drug.” In reference to the recommendation that the product be used as a second-line therapy, panellist Delbert Robinson remarked that “in terms of balancing the risks and benefits I think this would be acceptable.”

Concerns about potential side-effects linked to the use of the product, such as metabolic risk, sudden cardiac death and tardive dyskinesia, had previously been expressed by FDA staff in documents released ahead of the meeting. The FDA had indicated that the panel should consider the “public health implications” that could result from expanding the use of Seroquel XR to a much broader population.

Officials from AstraZeneca, meanwhile, stated there is no evidence that Seroquel XR increases the risk of sudden cardiac death. They said additional long-term studies are planned to evaluate diabetes and cardiovascular risks. The drugmaker’s chief medical officer, Howard Hutchinson, also explained that “we are not looking to promote the product for all patients with [MDD and GAD]…The goal is to provide a safe and effective option in patients for whom a first-line therapy is not appropriate.”

Source: FirstWord

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