AstraZeneca: FDA Concludes Seroquel XR Study >AZN

LONDON (Dow Jones)--AstraZeneca said Thursday that the Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) Advisory Committee concluded that SEROQUEL XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy.

SEROQUEL XR was shown to be acceptably safe as an adjunctive treatment for MDD.

SEROQUEL XR was not shown to be acceptably safe as a monotherapy for broad treatment for MDD.

The committee was undecided as to whether SEROQUEL XR was shown to be acceptably safe in certain instances as a monotherapy treatment for MDD.

SEROQUEL XR was not shown to be acceptably safe as a monotherapy for the treatment of GAD.

Howard Hutchinson, M.D., Chief Medical Officer said: "We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. 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 sNDAs."

SEROQUEL XR is not approved for the treatment of MDD and GAD.