26 December 2014 | News | By BioSpectrum Bureau
Takeda files NDA for multiple sclerosis drug in Japan
Glatiramer acetate is a multiple sclerosis therapy
Singapore: Takeda Pharmaceutical has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare for glatiramer acetate (active ingredient), for the relapse prevention of multiple sclerosis.
Developed by Teva Pharmaceutical located in Israel, glatiramer acetate for injection is indicated for the relapse prevention of multiple sclerosis.
Approved in 57 countries worldwide, glatiramer acetate is a leading multiple sclerosis therapy. In Japan, glatiramer acetate was developed as an unapproved new drug by Teva Pharmaceutical KK, a subsidiary of Teva, at the request of the Japanese Ministry of Health, Labour and Welfare.
In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize glatiramer acetate and Takeda has submitted the NDA under the terms of this agreement.