Spanidin (INN*1: gusperimus) filed in Europe for treatment of refractory Wegener's granulomatosis*2
2006/12/25
(This document is an English translation of the Japanese language original.)
Nippon Kayaku Co., Ltd. (Chiyoda-ku, Tokyo; President: Koichiro Shimada) announced that Euro Nippon Kayaku GmbH, its European subsidiary, has submitted a Marketing Authorization Application (MAA) of Spanidin (INN: gusperimus) to the European Medicines Agency (EMEA) for the treatment of refractory Wegener's granulomatosis on December 8, 2006.
Spanidin is an immunosuppressive agent with a unique mechanism of action and was approved for the treatment of rejection crisis after kidney transplantation in Japan in 1994. Orphan medicinal product designation for gusperimus for Wegener's Granulomatosis was granted in the European Union on March 2001 and led to the present filing. It is expected the drug will be approved and launched within 2008.
- *1 INN : International Non-propriatary Name
- *2 Wegener's granulomatosis : It is an autoimmune disease, accompanied by the antineutrophilic cytoplasmic antibody (ANCA). It is a systemic (more frequently occurring in the upper respiratory tract, lung and kidney) necrotizing/granulomatous angitis. Existing treatments permit recurrence in about 50% of cases, creating the potential for relapse. This refractory disease has no effective remedy, and requires a new treatment.
