Takeda Submits Application For New Multiple Sclerosis Relapse Prevention Drug Glatiramer Acetate in Japan

Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetate (active ingredient) — which is sold in some markets under the trade name Copaxone.

Developed by Israel’s Teva Pharmaceutical Industries Ltd., injectable glatiramer acetate is indicated for prevention of multiple sclerosis (MS) relapses and is a leading multiple sclerosis therapy in 57 countries worldwide so far, including United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

Glatiramer acetate was developed in Japan under Unapproved New Drug status by Teva’s Japanese subsidiary Teva Pharmaceutical K.K. at the Japanese Ministry of Health, Labour and Welfare’s request of. Takeda and Teva inked an agreement In March, 2013 whereby Teva granted commercialization rights for glatiramer acetate to Takeda, which has made the NDA submission under that agreement’s terms, and based on safety and efficacy results of a 52 week, open-label, clinical trial Teva Pharmaceutical K.K. conducted in Japanese relapsing-remitting multiple sclerosis patients as well as from clinical trials conducted by Teva from overseas.

Takeda has committed to work in close liaison with the Japanese regulator in order to make this medicine, which is currently in use first line MS treatment in other countries, available to Japanese MS patients.

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According to the U.S. National Multiple Sclerosis Society, glatiramer acetate/Copaxone is a synthetic protein that simulates the myelin basic protein component of myelin sheathing that insulates nerve fibers in the brain and spinal cord. The drug seems to block myelin-damaging T-cells in a way that is not completely understood. The NMSS notes that in controlled clinical trials on persons with relapsing-remitting MS, the group of subjects taking glatiramer acetate, which is injected subcutaneously (between the fat layer just under the skin and the muscles beneath), enjoyed a significant reduction in annual relapse rates and also reduction in new myelin lesions observed in magnetic resonance imaging (MRI), compared with control subjects who were given a placebo.

Glatiramer acetate is approved by the U.S. Food and Drug Administration (FDA) to reduce relapse frequency in relapsing-remitting MS patients, and the drug is also approved for medication of individuals who have experienced an MS first clinical episode (clinically-isolated syndrome) and who present with MRI features consistent with multiple sclerosis. The FDA approved a new 40 mg/mL dose of this medication January, 2014, to be injected three times per week — double the standard daily-injected 20 mg/mL dose that is injected daily. The larger-dose, lower-frequency approval was based on benefits and safety results in a one-year phase III trial that compared higher, less-frequent dosing of the medication with placebo. The standard dosing option continues to be available.

Glatiramer acetate side effects are typically mild, will resolve on their own and usually require no medical attention unless they continue for several weeks or are particularly bothersome.

Takeda Pharmaceutical Company Limited, originally founded in 1781, over its long corporate history of more than 230 years has developed a corporate philosophy of “Takeda-ism” (Integrity: Fairness, Honesty and Perseverance). Corporate activities are conducted according to the company’s corporate mission of striving toward better health for people worldwide through leading innovation in medicine. The Takeda group network of the spans more than 70 countries and regions worldwide — including Japan, the U.S., Europe, Latin America, Africa, the Middle East, and Asia Pacific, and its pharmaceutical products are marketed in approximately 100 countries worldwide, including marketing alliance partnerships with other companies.

Sources:
Takeda Pharmaceutical Company Limited
National Multiple Sclerosis Society