AstraZeneca obtained FDA approval for once-daily Seroquel XR extended-release tablets as adjunctive treatment to antidepressants in adults with major depressive disorder (MDD). The sNDAs for Seroquel XR as acute monotherapy and maintenance monotherapy, however, have not yet been sanctioned, with the FDA asking for additional information.

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FDA also recquires that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS) through 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.

FDA nod comes a day after AstraZeneca paid $200 million up front for global development rights Targacept’s MDD therapy. The drug is scheduled to enter Phase III trials next year, and Targacept could earn up to $1 billion if all milestones are met.

Seroquel XR was approved in the U.S. in 2007 for the treatment of schizophrenia in adult patients and in October 2008 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.

“Today’s FDA approval of Seroquel XR is based on a clinical-development program in MDD involving 939 patients randomized across two studies that assessed the efficacy and safety of once-daily treatment with Seroquel XR as adjunctive treatment to antidepressants,” says Lisa Schoenberg, vp specialty care.

Source: GEN News

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AstraZeneca reported that the Netherlands Health Authority refused its application for Seroquel XR (quetiapine) in the treatment of recurrent depressive episodes in adults with major depressive disorder (MDD). The drugmaker, which said it referred the application to a committee of the European Medicines Agency for further assessment, also announced that the antipsychotic drug was approved in Canada this month for the treatment of MDD.

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Company spokesman Neil McCrae explained that the refusal in the Netherlands, which was acting as the reference member state for the mutual recognition process, was due to the regulator’s conclusion that there was a “negative benefit risk.” He explained that if the EMEA’s Committee for Medicinal Products for Human Use issues a positive opinion for Seroquel XR for the MDD indication, approval in the EU could be expected in the first quarter of 2010.

Source: FirstWord

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An FDA advisory panel voted unanimously Wednesday that AstraZeneca’s Seroquel XR (quetiapine) was not safe enough for use as monotherapy in treating major depressive disorder (MDD), but members supported use of the antipsychotic drug as an add-on therapy for patients who are not responding to current treatments. The drug was rejected by the committee as a treatment for generalised anxiety disorder (GAD).

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The panel’s chairman, Wayne Goodman, commented that in comparison to older drugs, he saw “no clear advantage demonstrated in [Seroquel XR's] efficacy…There were side-effects, and I would expect unintended consequences associated with wide-scale use of the drug.” In reference to the recommendation that the product be used as a second-line therapy, panellist Delbert Robinson remarked that “in terms of balancing the risks and benefits I think this would be acceptable.”

Concerns about potential side-effects linked to the use of the product, such as metabolic risk, sudden cardiac death and tardive dyskinesia, had previously been expressed by FDA staff in documents released ahead of the meeting. The FDA had indicated that the panel should consider the “public health implications” that could result from expanding the use of Seroquel XR to a much broader population.

Officials from AstraZeneca, meanwhile, stated there is no evidence that Seroquel XR increases the risk of sudden cardiac death. They said additional long-term studies are planned to evaluate diabetes and cardiovascular risks. The drugmaker’s chief medical officer, Howard Hutchinson, also explained that “we are not looking to promote the product for all patients with [MDD and GAD]…The goal is to provide a safe and effective option in patients for whom a first-line therapy is not appropriate.”

Source: FirstWord

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In a warning letter to AstraZeneca posted to the FDA website, the US regulator stated that a sales representative recommended the company’s antipsychotic treatments Seroquel (quetiapine) and Seroquel XR to a physician for major depressive disorder (MDD), an unapproved use. “The representative…thus created a new ‘intended use’…for which the products lack adequate directions,” the agency noted.

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According to the FDA, in January a company sales representative suggested to a doctor that Seroquel and Seroquel XR were approved for the treatment of MDD. In response to the doctor requesting documentation supporting the claim, the company sent promotional materials including information about the drugs’ use in MDD and the results of eight clinical trials.

The promotional material sent to the physician stated that AstraZeneca does not recommend using the compounds in non-approved indications; however, the agency remarked that “this disclaimer is insufficient to mitigate the promotion of a new ‘intended use,’” and requested that the drugmaker immediately stop distributing any similar promotional materials.

AstraZeneca spokesperson Kirsten Evraire commented that the company “takes these allegations seriously, and we are conducting a full investigation.” She added that “although the allegations related to one isolated incident, AstraZeneca is taking steps to reinforce” policies for its sales force in regards to appropriate interaction with physicians.

In February the drugmaker filed for approval from the FDA to market Seroquel XR as a treatment for MDD. Seroquel had sales of more than $4 billion last year.

Source: FirstWord

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AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets 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. SEROQUEL XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.

Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition that consists of recurring episodes of depression and mania. Approximately eight million American adults may be affected by bipolar disorder.

“When people think about bipolar disorder it is important to remember how debilitating the depressive episodes of the disease can be. In fact, in the long term, patients with bipolar disorder experience depressive symptoms three times longer than manic symptoms” said Dr. Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Stanford University Medical Center and VA Palo Alto Health Care System. “With the approval of SEROQUEL XR for the treatment of bipolar depression and mania, we have a once-daily treatment that has been proven to help control the depressive and manic symptoms of bipolar disorder”

About bipolar disorder
Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterised by one or more manic or mixed episodes, often with one or more episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode. Patients with bipolar I disorder experience depressive symptoms – approximately three times longer than manic symptoms. Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania. Bipolar disorder is typically managed through a treatment strategy with several phases – including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com

Source: WebWire

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