AstraZeneca PLC (LSE: AZN) said an advisory panel to the US Food and Drug administration has concluded that Seroquel XR extended-release tablets are effective in treating major depressive disorder (MDD) and generalised anxiety disorder (GAD), but further discussions are required as there are still reservations about the safety of the drug.
The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) concluded that Seroquel XR is effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy.
While the drug was shown to be acceptably safe as an adjunctive treatment for MDD, it was not shown to be acceptably safe as a monotherapy for broad treatment for the condition.
The PDAC was undecided as to whether Seroquel XR was shown to be acceptably safe in certain instances as a monotherapy treatment for MDD.
The panel further found that Seroquel XR was not acceptably safe as a monotherapy for the treatment of GAD.
Howard Hutchinson, chief medical officer of AstraZeneca, said: “Although the committee recognised the effectiveness of SEROQUEL XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations. We look forward to having further discussions with the FDA regarding both drug applications.”
Seroquel XR is not approved for the treatment of MDD and GAD.