AstraZeneca will be celebrating news that its antipsychotic Seroquel XR has been given the European Commission’s seal of approval as an add-on treatment for major depressive episodes in patients with Major Depressive Disorder (MDD).
The news should come as somewhat of a relief to the Anglo-Swedish company, as Seroquel XR’s (quetiapine) path to market for MDD in Europe has certainly not been a smooth one.
In May 2009, the company referred its application to the European Medicines Agency’s Committee for Medicinal Products for Human Use seeking a central approval after regulators in The Netherlands, acting as reference state under the mutual recognition process, rejected the drug questioning its risk-benefit profile.
But the company’s move paid off, as in April this year the CHMP then backed AstraZeneca’s antipsychotic for MDD concluding that the potential benefits of the medicine outweigh its risks when used in patients who have an inadequate response to other antidepressants.
The EC has now followed suit issuing a positive decision for approval of the drug in this setting. AstraZeneca said its next move is to garner local approvals, which will be a 30-day process in the 17 member states that took part in the original Mutual Recognition Procedure but times in other states will vary.
Seroquel XR has racked up a substantial number of global approvals in schizophrenia, bipolar mania, bipolar depression, bipolar maintenance, Generalised Anxiety Disorder, and in MDD, and news that the drug is a step closer to a European launch as an add-on for MDD will be welcome indeed, especially as the firm’s big-earning Seroquel franchise is expected to face generic competition from September next year.