Drip Infusion 100 Receives Approval As Additional Indication Of Treating Behcet's Disease With Refractory Uveoretinitis

Tanabe Seiyaku Co., Ltd. has received approval for anti tumor necrosis factor (TNF)-a monoclonal antibody preparation REMICADE(R) for Drip Infusion 100 (generic name: infliximab) for extended indication of treating "Behcet's disease complicated with refractory uveoretinitis which does not respond to conventional therapies", for the first time in the world.

Behcet's disease is refracatory systemic inflammatory disease characterized by repeated episodes of relapses and recoveries, such as oral ulcer on the mucous membrane, dermatitis, uveoretinitis, and ulcer on the vulva. It is sometimes associated with inflammatory symptoms in the intestines, nerve, and vessel. As vision loss due to repeated ocular attacks is QOL (quality of life)-threatening, and suppression of frequency of ocular attacks is primarily important in the therapy.

It has been known from the recent researches that TNF-a, proinflammatory cytokine, is involved deeply in ocular attacks in uveoretinitis. REMICADE(R) produces a dramatic therapeutic effect in TNF-a involved inflammatory diseases by binding specifically to TNF-a and inhibiting its action, and it is expected to be highly effective also in uveoretinitis. As a result of the clinical study, it is proved that administration of REMICADE(R) in patients with Behcet's disease with refractory uveoretinits suppressed the frequency of ocular attacks.

Bechet's disease develops much in Japan, and nationwide, about 17,000 people are suffering from the disease. Tanabe Seiyaku will contribute to improve the patients' QOL through the proper use of REMICADE(R) by conducting post-marketing surveillance on all patients, and providing reliable safety information, as we have successfully completed in Rheumatoid Arthritis and Crohn's disease.

About Tanabe Seiyaku Co., Ltd.

Tanabe Seiyaku Co., Ltd. (TSE: 4508) is a manufacturer and distributor of pharmaceuticals for cardiovascular system, circulatory system, central nervous system, respiratory system and gastrointestinal system, tonics, antibiotics, chemotherapeutics, hormones, vitamins, diagnostic agents and mediums, as well as other products such as food additives and cosmetics. Operations are carried out through various divisions: prescription drugs, OTC drugs, diagnostic agents, animal drugs, chemicals, food additives, and dies/pigments.

Corporate Communications Division
Tanabe Seiyaku Co., LTD.
Corporate Communications Division