Safety and clinical benefits of AstraZeneca's Seroquel XR need to be demonstrated for its approval as an MDD monotherapy, says DR

The recent decision by the US Food and Drug Administration to grant approval of Anglo-Swedish drug major AstraZeneca's Seroquel XR (quetiapine fumarate) for adjunctive treatment of major depressive disorder will not change Decision Resources' market projection for the indication. As previously forecast by the research and advisory firm, Seroquel and Seroquel XR will garner nearly one quarter of antipsychotics sales as adjunctive treatments for major depressive disorder in 2013 in the world's major pharmaceutical markets.

The Pharmacor finding from the topic entitled Major Depressive Disorder shows that, although the FDA approved Seroquel XR as an adjunctive therapy, AstraZeneca will need to further demonstrate its safety and clinical benefits in order for the drug to gain approval as a monotherapy for the indication.

"After reviewing Seroquel XR's safety and efficacy data, the FDA's Psychopharmacologic Drugs Advisory Committee concluded that the drug was effective as both a monotherapy and an adjunctive therapy but was not acceptably safe as a monotherapy for broad treatment of major depressive disorder," said Decision Resources analyst Alana Simorellis. "The committee further recommended that the agent be used as supplemental treatment for patients with depression who do not achieve symptom relief from currently approved therapies," she noted.