The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Teva Pharmaceutical Industries' once-daily Copaxone (glatiramer acetate injection) 20mg injection for the prevention of relapse of multiple sclerosis. The product will be commercialised 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 commercialise Copaxone in Japan.
“Strengthening our offering of specialty medicines in Japan is an important goal for Teva. We are proud to work with Takeda in very close cooperation to make this product available to multiple sclerosis patients and the physicians treating them in Japan,” said Rob Koremans, MD, president and CEO Global Specialty Medicines at Teva.
“The partnership has been a success and we look forward to making additional specialty medicines available to Japanese patients.”
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.
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. The Copaxone brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.