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AstraZeneca's Seroquel XR Approved In EU As Add-on Treatment Of Major Depressive Disorder - Update

(RTTNews) - British drug maker AstraZeneca plc ( AZN, AZN.L) Thursday announced that the European Commission approved once-daily Seroquel Extended Release tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder or MDD, who have not responded well to antidepressant monotherapy.

The EC's decision follows a positive recommendation by the Committee for Medicinal Products for Human Use in April.

AstraZeneca said it would move forward in obtaining local approvals, a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure.

Seroquel XR is an extended release version of AstraZeneca's antipsychotic/antidepressant blockbuster Seroquel.

To date, Seroquel XR has been approved in 72 countries for schizophrenia, 57 countries for bipolar mania, 49 countries for bipolar depression, 33 countries for bipolar maintenance, six countries for MDD, with US receiving approval of Seroquel XR for the adjunctive treatment of MDD in December 2009, and three countries for Generalised Anxiety Disorder.

Seroquel, was originally approved by the FDA in 1997 to treat the symptoms of schizophrenia. The drug was approved to treat acute manic episodes associated with bipolar I disorder in 2004 and for the treatment of patients with depressive episodes associated with bipolar disorder in 2006.

In addition to the approved uses, Seroquel has been used off-label to treat anxiety, obsessive compulsive disorders, dementia and autism.

According to IMS, Seroquel was the fifth-best-selling drug in the US last year and for the second quarter of 2010, it contributed US$1.35 billion to the total second quarter Group revenues of US$8.18 billion.

However, AstraZeneca been facing product liability lawsuits over the dug, related to the allegation that it failed to warn about the increased risk of diabetes, weight gain or death. According to the company, about 17,500 Seroquel product liability suits in the United States have been settled for approximately $198 million.

In Wednesday's regular trading session, AZN closed trading at $50.49 per share on the NYSE.

AZN.L is currently trading at 3,281.50 pence per share, down 3.50 pence per share or 0.11%, on the London Stock Exchange.