AstraZeneca: More Good News - Analyst Blog

Good news for AstraZeneca (AZN) once again! The company received US Food and Drug Administration (FDA) approval for Seroquel XR (quetiapine fumarate) as an add-on treatment to antidepressants in adults with Major Depressive Disorder (MDD).

Seroquel XR is an extended-release version of the company’s currently marketed Seroquel, which is approved for the treatment of bipolar disorder and schizophrenia.The approval comes shortly after AstraZeneca’s announcement of a billion dollar deal with Targacept (TRGT) for the development of a depression drug.

However, the company received a complete response letter (CRL) from FDA for Seroquel’s approval as a first-line treatment for MDD. The agency has asked the company to undertake a Risk Evaluation and Mitigation Strategy (REMS) for all approved indications of Seroquel. This requires a proper survey of patients to ensure their understanding of the potential risks of the drug. The company will continue its discussions with the regulators and expects to respond to the CRL in due course.

In another development, AstraZeneca received FDA approval for Seroquel for the treatment of schizophrenia in adolescents (13-17 years of age) as a single agent as well as for the treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an add-on treatment to lithium or divalproex.

MDD is a common illness affecting approximately 42 million people worldwide. Seroquel is one of the biggest selling drugs of AstraZeneca, with global sales of about $4.5 billion in 2008. We believe additional approval of the drug will further boost its sales given the huge potential of the global antidepressant market, which is valued at over $20 billion.
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