Osaka, Japan, November 26, 2015—Takeda Pharmaceutical Company Limited announced today that the multiple sclerosis treatment drug, "Copaxone® Subcutaneous Injection 20 mg Syringe" (generic name: glatiramer acetate, hereinafter "Copaxone") has become available in Japan.
This drug has been developed by Teva Pharmaceutical Industries Ltd. (Head office Petah Tikva, Israel hereinafter "Teva") as a subcutaneous injection administered once daily, to prevent the relapse of multiple sclerosis. Copaxone was designated as an orphan drug by the Japanese Ministry of Health, Labour and Welfare (MHLW) in March 2009, and a request was received from the MHLW in May 2010 for its development as an "unapproved drug highly needed in medical care". In March 2013, Takeda and Teva entered into a licensing agreement for commercialization of this drug in Japan, and on September 28, 2015 Takeda obtained NDA approval. It was listed in the NHI (National Health Insurance) Price List today.
Multiple sclerosis is assumed to be an autoimmune disease, the hallmark sign of which is inflammatory demyelination of the central nervous system characterized by demyelinating plaques in the brain and the spinal cord. Common symptoms of multiple sclerosis include visual problems, ocular motor abnormality, paresthesia, muscle weakness, spasticity, urinary dysfunction, and cognitive impairment. This disease may present as a primary progressive type, which takes a chronic progressive course from its early onset; a relapsing-remitting type, which repeats a pattern of relapse and remission; or a secondary progressive type that shifts to a progressive course later. More than 80% of patients are categorized as having the relapsing-remitting type. Multiple sclerosis is estimated to affect approximately 18,000 individuals in Japan, with its prevalence tending to increase.
"Copaxone, one of the most frequently used drugs in multiple sclerosis, is approved in more than 50 countries worldwide, and is expected to represent a new treatment option for Japanese patients," said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda. "Takeda will continue to be committed to delivering drugs for diseases that remain as high unmet medical needs for both patients and physicians".
Overview of Copaxone
|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: 20 mg of glatiramer acetate once daily.|
|Drug Price||5,617 yen|
About Glatiramer Acetate
Glatiramer acetate was developed by Teva as a subcutaneous injection administered once daily to prevent the relapse of multiple sclerosis. Teva Pharmaceutical K.K., the Japanese subsidiary of Teva, (a 100% owned subsidiary of Teva, Head Office: Minato-ku, Tokyo) has been developing the drug for clinical use in Japan. This drug suppresses inflammation in the central nervous system by modulating immune responses to multiple sclerosis, thereby preventing relapses. This drug has also been indicated overseas for relapsing forms of multiple sclerosis. Its most common side effects include 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 EU countries.
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, www.takeda.com.
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