AstraZeneca's Seroquel gets EU approval for bipolar recurrence

AstraZeneca says that its once-daily Serooquel XR (quetiapine fumarate extended-release tablets) and Seroquel have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.

Following this new indication, the two formulations are the only agents approved in the European Union to treat all phases of bipolar disorder - acute depressive episodes, acute manic episodes and maintenance treatment to prevent recurrence of any mood event in bipolar disorder.

The Anglo-Swedish drug major added it would now move to obtain local approvals in the Mutual Recognition Procedure countries of Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Malta, Portugal, Poland, Spain and Sweden. The drug is under review in the USA.

AstraZeneca noted Seroquel XR has previously been approved in 63 countries for treating schizophrenia, 38 for bipolar mania, in 37 countries for bipolar depression, in nine markets for bipolar maintenance, in one market for generalized anxiety disorder and in three markets for major depressive disorder.

Seroquel sales in the first quarter amounted to $1.12 billion or 14.5% of AstraZeneca's revenue in the period.