New Drug Application Approval in Japan for Copaxone® Subcutaneous Injection 20 mg Syringe, a Drug for the Treatment of Multiple Sclerosis

New Drug Application Approval in Japan for Copaxone® Subcutaneous Injection 20 mg Syringe, a Drug for the Treatment of Multiple Sclerosis

September 28, 2015

Osaka, Japan, September 28, 2015— Takeda Pharmaceutical Company Limited (TSE:4502) today 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.

Granting of this approval in Japan represents an extremely important milestone for Takeda, and we expect that this drug, which is the first-line therapy overseas for relapsing-remitting multiple sclerosis, can contribute to the therapy of Japanese patients with multiple sclerosis. We will continue to make efforts to deliver drugs that are needed by patients and healthcare professionals.

Overview of Copaxone

Brand nameCopaxone® Subcutaneous Injection 20 mg Syringe
Generic nameGlatiramer acetate
IndicationsPrevention of relapse of multiple sclerosis 
Dosage and administration

The usual adult dosage for subcutaneous injection is 20 mg 
of glatiramer acetate once a day. 

About Glatiramer Acetate
Glatiramer acetate is indicated for the prevention of relapse frequency of recurrent multiple sclerosis outside Japan. The most common side effects of the medicine are injection site reactions (erythema, pain, mass, pruritus, and edema). It is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

About Multiple Sclerosis
Multiple sclerosis is believed to be an autoimmune disease, the cardinal sign of which is inflammatory demyelination of the central nervous system characterized by demyelinating plaques in the brain and the spinal cord. Common symptoms include visual problems, ocular motor abnormality, paresthesia, muscle weakness, spasticity, urinary dysfunction, and cognitive impairment. The disease is categorized into three types: (1) a primary progressive type which takes a chronic progressive course from the onset, (2) a relapsing-remitting type which repeats a relapse and remission, and (3) a secondary progressive type which shifts to the progressive course later. More than 80% of patients are categorized into the relapsing-remitting type. The morbidity in patients is estimated to be approximately 18,000 in Japan, and its prevalence shows an increasing trend. 

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website,


Tsuyoshi Tada
Takeda Pharmaceutical Company Limited
E-mail: [email protected]