OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TOKYO: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.
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Overview of Copaxone |
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| Brand name | Copaxone® Subcutaneous Injection 20 mg Syringe | |
| Generic name | Glatiramer acetate | |
| Indications | Prevention 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 (TOKYO: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, www.takeda.com.
