AstraZenca’s Seroquel XR (quetiapine fumarate) has been given a positive decision by the European Commission (EC).
Following a recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April, the extended release tablets can now be given to patients with major depressive disorder (MDD) who have not responded to antidepressant monotherapy.
AstraZeneca must now obtain local approvals over the next month in the 17 member states that took part in the mutual recognition procedure.
The decision from the EC follows a similar recommendation from the FDA in the US.
Seroquel is AZ’s second-biggest selling drug despite being involved in US lawsuits including thousands of plaintiffs. Last month AstraZeneca announced it was to pay £198 million to settle two-thirds of cases after claims Seroquel caused diabetes in a number of patients.
Weight gain is one of the areas of product information to be updated within the EU application, along with suicidality, hyperglycaemia, somnolence, orthostatic hypotension, and dizziness.
The drug has already been approved in a number of countries for schizophrenia, bipolar mania, bipolar depression, MDD and generalised anxiety disorder.