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European MDD approval for Seroquel XR

The European Commission has approved AstraZeneca's Seroquel XR as an add-on treatment for major depressive disorder

The European Commission (EC) has approved AstraZeneca's (AZ) Seroquel XR (quetiapine fumarate) as an add-on treatment for major depressive disorder (MDD) for patients who have shown poor response to antidepressant monotherapy.

The EC Member States had previously rejected a change to Seroquel XR's market authorisation to recommend the drug under these conditions for MDD, with the benefit-risk balance of the medicine seen as 'unfavourable'.

AZ disagreed with the grounds for refusal, however, and referred the matter to the EC's Committee for Medicinal Products for Human Use (CHMP) for arbitration.

The CHMP later gave a positive recommendation for the indication in April 2010, after an evaluation of available data and a scientific discussion within the Committee.

Product information for Seroquel XR has also been updated with the application for EC approval to include guidance concerning such safety issues as suicidality, weight gain, hyperglycaemia and dizziness.

The Seroquel franchise of Seroquel XR and Seroquel IR had faced controversy in recent years over claims AZ did not provide adequate warning concerning weight gain and diabetes issues involved with the drug.

In August 2010, the company announced it has reached agreements in principle on monetary terms with attorneys representing around 17,500 Seroquel product liability claimants in the US for around $198m. Many of the suits also claimed AZ promoted the drug for unapproved uses.

Seroquel XR is currently approved in 72 countries for schizophrenia, 29 countries for bipolar depression and 6 countries for MDD. The drug received US approval for the adjunctive treatment of MDD in December 2009.

2nd September 2010

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