Takeda Pharmaceutical Company has obtained the New Drug Application approval for Copaxone® Subcutaneous Injection 20 mg Syringe (generic name: glatiramer acetate), a drug for the treatment of multiple sclerosis, from the Japanese Ministry of Health, Labour and Welfare.
Developed by Teva Pharmaceutical Industries Ltd. (Teva), Copaxone® is a subcutaneous injection administered once daily to prevent the relapse of multiple sclerosis. Copaxone® is one of the most frequently-used drugs in multiple sclerosis therapy and is approved in more than 50 countries worldwide.
In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the Japanese Ministry of Health, Labour and Welfare. In March, 2013, Takeda and Teva signed a licensing agreement in which Teva granted Takeda the right to commercialize glatiramer acetate in Japan. Takeda submitted the NDA in December 2014 under the terms of this agreement.
The approval is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted in Japan by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis as well as 3 clinical trials from overseas conducted by Teva in patients with relapsing-remitting multiple sclerosis.