AstraZeneca plc went into last week's FDA advisory committee meeting asking for an expansion of the labeled indication for its Seroquel XR quetiapine that could have allowed it to promote the drug for conditions that affect tens of millions of Americans. It came away with a recommendation from the Psychopharmacologic Drugs Advisory Committee that FDA widen the label only slightly beyond the current indications of schizophrenia and bipolar disorder, and that the agency and the pharma take steps to prevent a dramatic expansion of the number of patients who receive the drug.
The committee agreed with FDA that AstraZeneca has demonstrated efficacy of Seroquel XR as a monotherapy and adjunctive therapy to treat major depression, and as a monotherapy to treat generalized anxiety. But the committee was concerned about an observational study that demonstrated an association between atypical antipsychotics and sudden cardiac death, as well as the possibility that Seroquel XR causes tardive dyskinesia.
In addition to potential risks, panel members said adverse effects seen in post-market safety databases, especially metabolic effects such as weight gain, hyperlipidemia, and hyperglycemia, indicate Seroquel XR should not be used in a broad population for conditions such as depression and anxiety that can be treated with safer drugs.
The committee revised the questions FDA asked, splitting the question on whether Seroquel XR is safe for major depressive disorder (MDD) and general anxiety disorder (GAD) into separate votes