MAA of Spanidin (INN*1: gusperimus) withdrawn in Europe
2008/6/20
(This document is an English translation of the Japanese language original.)
Nippon Kayaku Co., Ltd. (Chiyoda-ku, Tokyo; President: Koichiro Shimada) decided on June 17, 2008 to withdraw a Marketing Authorization Application (MAA) of Spanidin for the treatment of Wegener's granulomatosis*2.
The company recognized the difficulty in responding to assignments given in the course of examination of the MAA within an appropriate period of time, even though it had Euro Nippon Kayaku GmbH, its European subsidiary, serve as the applicant in the MAA to European Medicines Agency.
- *1INN : International Non-propriatary Name
- *2Wegener'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.
