Osaka, Japan, December 25, 2014— Takeda Pharmaceutical Company Limited (Takeda) announced today that it has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for glatiramer acetate (active ingredient), for the relapse prevention of multiple sclerosis.
Developed by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) located in Israel, glatiramer acetate for injection is indicated for the relapse prevention of multiple sclerosis. Approved in 57 countries worldwide, glatiramer acetate is a leading multiple sclerosis therapy.
In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a subsidiary of Teva, at the request of the Japanese Ministry of Health, Labour and Welfare. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize glatiramer acetate and Takeda has submitted the NDA under the terms of this agreement.
This application 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 data from overseas clinical trials conducted by Teva.
Takeda will continue to work closely with the regulatory agency to bring this medicine, which is used for the first line treatment of the disease outside Japan, to Japanese patients.
About Glatiramer Acetate
Glatiramer acetate is indicated for the relapse prevention of 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 57 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries, and is marketed under the brand name COPAXONE®.
About Multiple Sclerosis
Multiple sclerosis is an autoimmune disease, the cardinal sign of which is inflammatory demyelinating disorder of the central nervous system characterized by demyelinating plaques in the brain and 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) Primary progressive type, which takes a chronic progressive course from the onset, (2) Relapsing-remitting type, which repeats relapse and remission, (3) Secondary progressive type, which shifts to the progressive course later even in a case with repeated relapse and remission, more than 80% of the patients are categorized into the relapsing-remitting type. The morbidity in patients is estimated to be approximately 16,000 and its prevalence shows a trend of increasing in Japan.