Teva Pharmaceutical Industries Ltd. announced the approval by the Japanese Ministry of Health, Labour and Welfare
(MHLW) of once-daily COPAXONE® (glatiramer acetate injection)
20mg injection for the prevention of relapse of multiple sclerosis . The
product will be commercialized in Japan by Takeda Pharmaceutical Company
Limited (Takeda).
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 MHLW. In March, 2013, Takeda and Teva signed an agreement
in which Teva granted Takeda the right to commercialize COPAXONE®
in Japan.
The Japanese approval for COPAXONE® is based on the safety
and efficacy results of an open-label, 52-week clinical trial conducted
by Teva Pharmaceutical K.K. in patients with relapsing-remitting
multiple sclerosis in Japan as well as the pivotal trial data sets used
for approvals in other countries.
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain.
