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2005 News Releases

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Luvox® Receives Approval for Social Anxiety Disorder as an Additional Indication

October 12, 2005

Japan, October 12, 2005 - Astellas Pharma Inc. (Head Office: Tokyo, President & CEO: Toichi Takenaka, hereafter referred as "Astellas") today announced that the antidepressant "Luvox® Tablet" (generic name: fluvoxamine maleate) was approved for "social anxiety disorder (SAD)" as an additional indication on October 11, 2005.

SAD is defined as excessive anxiety and fear about possible exposure to other people such as meeting someone, stating their opinion at a meeting, and making a telephone call in the presence of another person, etc. Patients with SAD are so afraid of these situations that they try to avoid them, resulting in interference in their activities of daily living. Some patients experience further serious problem such as alcohol dependency or depression to suppress these anxiety.

Luvox® Tablet is expected to contribute to improvement of quality of life (QOL) of SAD patients by eliminating their anxiety and fear to suppress symptoms such as diaphoresis and blushing (flushes) and to reduce aversive behaviors due to fear and anxiety. In Japan, there has been no drug indicated for SAD up until now. The agent is the first drug approved for this disorder in Japan.

Discovered by Solvay Pharmaceuticals, the Netherlands, and developed by Solvay Seiyaku K. K. and Meiji Seika Kaisha Ltd. in Japan, Luvox® Tablet is the first SSRI (selective serotonin reuptake inhibitor) launched in Japan ("Depromel" brand name by Meiji Seika for reference). Since it was launched in Japan in 1999, Luvox® Tablet has contributed to the treatment of "depression/depressive state" and "obsessive compulsive disorder." With the approved additional indication, it is expected to further contribute to the improvement of QOL of patients.

Astellas has a strong presence in the market for CNS diseases. The Company aims at further contributing to the treatment of CNS diseases by continuing to market Luvox® Tablet as one of its top priority products and deploying MRs specialized in the CNS field.

 

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