AZ’s Seroquel extends European licence
pharmafile | September 3, 2010 | News story | Sales and Marketing | AstraZeneca, Seroquel
AstraZeneca’s controversial anti-psychotic drug Seroquel has been given the green light in Europe as an add-on treatment for serious depressive episodes.
Following a recommendation by the Committee for Medicinal Products for Human Use in April, the European Commission has followed through on its advice for once-daily Seroquel XR (quetiapine fumarate).
The extended release tablets can now be given to patients with major depressive disorder (MDD) who have have not responded adequately to antidepressant monotherapy.
It follows a similar decision by US authorities, although last month AstraZeneca announced it was to pay £198 million to settle US lawsuits over claims Seroquel caused diabetes in a number of patients.
Despite the controversy, Seroquel remains the company’s second-biggest selling drug, with sales of $4.9 billion last year and sales up 10% in the first half of 2010.
Many of the US suits were based around the idea that patients had been insufficiently aware of possible side effects, and the multi-million dollar payout covers two-thirds of the 17,500 claimants.
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 next stage is for AstraZeneca to obtain local approvals over the next month in the 17 member states that took part in the mutual recognition procedure. These include Ireland, Germany, Spain, Netherlands, Sweden and Poland.
Seroquel XR has already been approved in various countries for schizophrenia, bipolar mania, bipolar depression, MDD and generalised anxiety disorder.
Meanwhile the US regulator the FDA has asked MedImmune, AstraZeneca’s biologics unit, for more information on its investigational monoclonal antibody motavizumab.
The company hopes for an indication to prevent serious respiratory syncytial virus (RSV) disease, but the FDA wants evidence from an additional clinical trial that supports a satisfactory risk/benefit profile.
Adam Hill
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