US FDA approves AstraZeneca’s Seroquel XR for add-on treatment of MMD and standard drug for pediatric use

Article | 4 December 2009

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The US Food and Drug Administration has approved Anglo-Swedish drug major AstraZeneca’s once-daily blockbuster drug Seroquel XR (quetiapine fumarate) extended release tablets as adjunctive (add-on) treatment to antidepressants in adults with major depressive disorder (MDD).

The FDA also cleared standard Seroquel for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex.

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Seroquel is a big money spinner for AstraZeneca, generating sales of $3.6 billion in the first nine months of the year, $2.5 billion of which came from the US market, up 16% on the previous year’s three-quarter total. The news saw the UK-headquartered company’s share price rise just over 0.9% to £27.97 on the London market where the FTSE 100 dipped 0.6% in morning trading.

...but also calls for additional information

In addition to the FDA approval for the adjunctive indication in MDD, AstraZeneca says it has received a Complete Response Letter from the FDA asking for additional information for the supplemental New Drug Applications for Seroquel XR as acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients. The CRL does not change the current recommendations for the treatment of patients taking the drug for approved indications in schizophrenia and bipolar disorder.

The FDA has required that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS) for Seroquel XR, which requires a Medication Guide and periodic assessments that will include a survey of patients' understanding of the potential risks of the drug. The REMS applies to all approved indications, the company noted.