Teva wins approval for COPAXONE to prevent relapse of multiple sclerosis

Teva wins approval for COPAXONE to prevent relapse of multiple sclerosis

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The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Teva Pharmaceutical Industries‘ once-daily COPAXONE (  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.

Teva president and CEO for global specialty medicines Rob Koremans said: “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.

“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.

Published 30 September 2015

 Source: Company Press Release
http://regulatoryaffairs.pharmaceutical-business-review.com/
September 30, 2015 / Pharma News