Seroquel XR MDD indication given CHMP nod
This article was originally published in Scrip
The EU's CHMP has endorsed AstraZeneca's atypical antipsychotic Seroquel XR (quetiapine fumarate extended-release) as an add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
The decision is a product of an arbitration procedure initiated by AstraZeneca after the supplemental marketing application was rejected by the Netherlands regulatory agency, where it was filed under the mutual recognition procedure (MRP) last May (scripnews.com, 29 May 2009).
At the time, the Dutch regulators said that the benefit:risk ratio of the drug was unfavourable, that not enough data had been submitted to support the restriction to patients not responsive to standard antidepressants and that evidence in support of the proposed dose was insufficient.
AstraZeneca told Scrip that all EU member states were involved in the CHMP assessment and have voted their opinion. Since the decision was a product of arbitration, only the member states of the MRP are bound by the outcome (in addition to the Netherlands, these were Austria, Belgium, Cyprus, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Luxembourg, Malta, Norway, Poland, Portugal and Sweden). The company added that it anticipates that non-MRP member states, which include the UK, will give consideration to the committee's verdict.
In the EU, Seroquel XR is also approved for the treatment of schizophrenia, moderate-to-severe manic and major depressive episodes associated with bipolar disorder and the prevention of recurrence of bipolar disorder. It is available in 50mg, 150mg, 200mg, 300mg and 400mg tablets.
In the US, Seroquel XR is approved as an adjunctive to other antidepressants for adult patients with MDD, the treatment of schizophrenia, and for the acute and maintenance treatment of bipolar disorder.