Wednesday, British pharmaceutical major AstraZeneca Plc (AZN,AZN.L) said that the U.S. Food and Drug Administration, or FDA, asked for additional information for the supplemental New Drug Application for Seroquel XR, the extended release tablets for treating major depressive disorder, or MDD, in adult patients.
The company is evaluating the contents of the regulator's letter and the proposed labelling revisions. AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course.
The Complete Response Letter or CRL from FDA does not change the current recommendations for the treatment of patients taking Seroquel XR or Seroquel for approved indications in schizophrenia and bipolar disorder.
Seroquel XR, a once-daily, extended release formulation of Seroquel, was approved in the U.S. in 2007 for the acute and maintenance treatment of schizophrenia in adult patients. In October, 2008, the drug was approved in U.S. for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
The once-daily formulation Seroquel XR and Seroquel was also approved in mid-November under the European Mutual Recognition Procedure, or MRP, for new indications in bipolar disorder. Both formulations have earlier been approved for the treatment of major depressive episodes in bipolar disorder. AstraZeneca also had said that it will move forward with obtaining local approvals with the 17 European Union, or EU member states that take part in the Mutual Recognition Procedure.
The company had noted that Seroquel is currently the only atypical antipsychotic approved to treat the spectrum of mood episodes associated with bipolar disorder and the only licensed treatment for bipolar depression in the EU.
It was in October that AstraZeneca submitted Seroquel XR to European regulatory authorities seeking approval for both short-term and maintenance treatment of Generalised Anxiety Disorder, GAD. It was the first time approval has been sought in Europe for an atypical antipsychotic medicine for the treatment of GAD.
In a different development, AstraZeneca, on November 28 had said that its wholly owned biologics business MedImmune has received a CRL from FDA asking for additional information on motavizumab, an investigational monoclonal antibody. The CRL was in connection with the Biologics License Application, or BLA, for motavizumab for the prevention of serious respiratory syncytial virus disease, which was submitted on January 30, 2008.
AZN closed its trading on Tuesday at $39.72, down $0.58 or 1.44%, on a volume of 819 thousand shares. In the past 52 weeks, shares have been trading in a range of $32.58 - $49.85.
AZN.L is currently trading on the LSE at 2,664 pence, down 47 pence or 1.73%, on a volume of 156 thousand shares.
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