Copaxone, marketed by Takeda, is already approved for use in some 50 countries

Takeda Pharmaceutical Co. Ltd., a pharmaceutical company based in Osaka, Japan, recently announced that a widely approved drug treatment for the prevention of relapses in multiple sclerosis (MS) is now available in Japan as well.

Copaxone, (glatiramer acetate; 20 mg daily subcutaneous injection), developed by Teva Pharmaceuticals Industries Ltd., is an immunomodulatory drug designed to act as a decoy for the exacerbated immune system in MS, reducing inflammation in the central nervous system. The drug is a random polymer of four basic amino acids found in myelin. Copaxone has been shown to reduce the relapse frequency in patients with remitting or relapsing MS.

MS is estimated to affect approximately 18,000 people in Japan. In 2009, the Japanese Ministry of Health, Labour and Welfare (MHLW) gave orphan drug designation to Copaxone, a special status given to drugs for the treatment of rare conditions. In the following year, MHLW supported the development of Copaxone as an “unapproved drug highly needed in medical care.” Takeda and Teva entered into a license agreement for the commercialization of Copaxone in Japan in 2013, and Takeda obtained approval for a new drug application (NDA) for Copaxone in September 2015, enabling its sale and marketing.

“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 Dr. Masato Iwasaki, director and president, Japan Pharma Business Unit of Takeda, in a press release. “Takeda will continue to be committed to delivering drugs for diseases that remain as high unmet medical needs for both patients and physicians.”

Copaxone has been approved for use in the United States, Canada, Mexico, Australia, Russia, Israel, the EU, and other countries.

MS is an autoimmune disease in which the myelin sheath that covers and protects neurons is destroyed by the body’s own immune system, a process known as demyelination, leading to irreversible neurological disability and motor function impairment. MS patients may experience relapses (disease exacerbations or flare-ups), which are characterized by the worsening of neurological function.