ENBREL to Add Indication of Juvenile Idiopathic Arthritis (JIA)

Wyeth and Takeda Pharmaceutical announced that on July 7, 2009 Wyeth had received approval from the Japanese Ministry of Health, Labour and Welfare to add the indication of treating polyarticular Juvenile Idiopathic Arthritis (JIA) to “ENBREL 25mg for S.C. Injection,” (etanercept) which Wyeth and Takeda co-promote

Tokyo and Osaka, Japan | July 8, 2009 | Wyeth K.K. (Wyeth) and Takeda Pharmaceutical Company Limited (Takeda) announced that on July 7, 2009 Wyeth had received approval from the Japanese Ministry of Health, Labour and Welfare to add the indication of treating polyarticular Juvenile Idiopathic Arthritis (JIA) to “ENBREL 25mg for S.C. Injection,” (etanercept) which Wyeth and Takeda co-promote. On the same day, Wyeth also received approval for the addition of “ENBREL 10mg for S.C. Injection,” a 10-mg dose of the product.

“In 1999, Enbrel became the first biologic product in the world to be approved for JIA and has since been used by many patients globally. I am delighted that we will now also be able in Japan to provide Enbrel to JIA patients.” said Wyeth KK President Michael Goettler regarding the additional indication. “As demonstrated by the safety data gained from a post-marketing study of all 14,000 cases of use of ENBREL in adult RA in Japan, we will continue to work to maximize the added value of ENBREL, and will endeavor to offer patients and medical professionals in Japan the opportunity to have diverse options for treatment of related conditions.”

“JIA is a disease which limits daily activities of the patients due to continued arthritis,” said Yasuhiko Yamanaka, Member of the Board, General Manager of Pharmaceutical Marketing Division of Takeda. “Takeda and Wyeth expect to contribute to the improvement of QOL of the patients with JIA by offering this new treatment option, which can be administered by patients themselves, and accordingly, can save the time and physical burden for patients when visiting physicians’ office.”

Sales of the 10-mg dose will begin after it is entered into the NHI drug price listing.


Active Juvenile Idiopathic Arthritis in multiple joints (Only for patients with an inadequate response to prior conventional therapy)

Subcutaneous injection of etanercept once daily, twice per week, at a dosage of 0.2 - 0.4 mg/kg. (upper limit for one injection is standard dosage for adults, 25mg)


Juvenile Idiopathic Arthritis(JIA) is a chronic inflammatory disorder of unknown cause, which afflicts children under the age of 16 and mainly affects the joints, and the number of patients in Japan is approximately 3,000[*1] and it is estimated that around 30% is polyarticular JIA[*2].

[*1] MHLW Infant drug treatment review commission report No. 15-2
[*2] Shuji Takei et al. Secondly Research for JIA using the child chronic specified disease research enterprise: report 102-113, 2008


ENBREL, a fully human soluble TNF-alpha/LT-alpha receptor, was approved in Japan in 2005 for the treatment of rheumatoid arthritis (RA) patients who did not get effective relief from existing therapy. By binding to TNF-alpha/LT-alpha, which plays a major role in the inflammation process in RA, ENBREL biologically de-activates TNF, and significantly reduces the inflammation associated with RA. Globally physicians have become familiar with the benefits and proven long-term profile of ENBREL. To date, the product has been approved in more than 70 countries around the world, and has been used to treat more than 500,000 patients worldwide across various indications.


Wyeth K.K. is engaged in a full range of pharmaceutical business activities including developing, importing and marketing pharmaceutical products with the aim of becoming a leading company in the pharmaceutical industry in Japan. Our corporate vision is Leading the way to a healthier world. We strive to achieve this vision by bringing to the world pharmaceutical and health-care products that improve peoples’ lives and deliver outstanding value to our customers. Headquartered in Tokyo, Wyeth K.K. has approximately 1,000 employees. See details, at www.wyeth.jp.


Located in Osaka, Japan, Takeda 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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Takeda is enhancing its R&D pipeline by concentrating its management resources in the following selected core therapeutic areas: “lifestyle-related diseases,” “oncology and urological diseases (including gynecology),” “central nervous system diseases (including bone and joint disorders,” and “gastroenterological diseases.” For more information, please visit http://www.takeda.com/.

SOURCE: Takeda Pharmaceutical Company Limited

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