Orencia® for Intravenous Infusion 250 mg, Selective T-cell Co-stimulation Modulator: Approval for Additional Indication of Active Polyarticular Juvenile Idiopathic Arthritis for Partial Change in Approved items of Manufacturing and Marketing Approval in Japan (168KB)

Bristol-Myers Squibb K.K. Ono Pharmaceutical Co., Ltd.

Orencia® for Intravenous Infusion 250 mg, Selective T-cell Co-stimulation Modulator: Approval for Additional Indication of Active Polyarticular Juvenile Idiopathic Arthritis for Partial Change in Approved items of Manufacturing and Marketing Approval in Japan

Bristol-Myers Squibb K.K. (Head office: Shinjuku, Tokyo; Representative Director and President: Jean-Christophe Barland; "BMSKK") and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka; President, Representative Director, Gyo Sagara; "Ono") announced today the approval of Orencia® for Intravenous Infusion 250 mg (generic name: abatacept, "Orencia"), a selective T-cell co-stimulation modulator, for additional indication of active polyarticular juvenile idiopathic arthritis (JIA) for a partial change in approved items of the manufacturing and marketing approval in Japan.

Juvenile idiopathic arthritis (JIA) is defined as arthritis of unknown etiology that begins under the age of 16 and persists for more than 6 weeks. In Japan, the prevalence of JIA is estimated at 10-15 cases per 100,000 pediatric population*.

In the treatment of JIA, non-steroidal anti-inflammatory drugs (NSAIDs) and biologic products such as IL-6 inhibitors and TNFα inhibitors have been used, but these drugs are not always effective for all patients. Some patients cannot continue treatment with these drugs due to adverse drug reactions, and there is a need for new treatment options with mechanisms of action that differ from currently available drugs.

Orencia has a different mechanism of action from other existing drugs. It suppresses the activation of T-cells by binding specifically with the CD80 and CD86 on the surface of the antigen-presenting cells. Orencia has been already approved for the treatment of active JIA in the US, EU, etc.

Through activities designed to communicate information about the product and promote its proper use, BMSKK and Ono are committed to contributing to the health of patients with JIA.

*: "Guidance on primary care for juvenile idiopathic arthritis 2017" by The Pediatric Evaluation Committee of the Japan College of Rheumatology, published by Medical Review Co., Ltd.

Orencia® for Intravenous Infusion 250 mg

Note: The underlined parts show the revised ones according to this approval.

About Orencia

Orencia is a genetically recombinant soluble fusion protein that consists of the extracellular domain of cytotoxic T-lymphocyte-antigen-4 (CTLA-4) linked to the Fc portion of human IgG1. Orencia is a biologic product that suppresses activation of T-cells by binding specifically with CD80 and CD86 on the surface of the antigen-presenting cells and improves signs and symptoms, physical functions, and health-related quality of life in patients with rheumatoid arthritis. It was first approved in the US in December 2005 as a treatment for rheumatoid arthritis, and is now approved in more than 50 countries worldwide. In Japan, manufacturing and marketing approval for the drug as an intravenous infusion was received in July 2010, followed by approval as a subcutaneous syringe formulation in June 2013 and for the subcutaneous auto-injector formulation in February 2016.

About Collaboration between Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd.

Bristol-Myers Squibb and Ono concluded a co-commercialization agreement for Orencia on September 21, 2011. Bristol-Myers Squibb K.K. and Ono initiated co-promotion activities from June 4, 2013. Orencia has been jointly developed by both companies.

About Bristol-Myers Squibb K.K.

Bristol-Myers Squibb is a global specialty biopharmaceutical company with more than 130 years of history, operating worldwide. With the mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases, the company concentrates its R&D efforts on four key disease areas, "Oncology," "Immunoscience," "Cardiovascular" and "Fibrosis." Established in 1960, Bristol-Myers Squibb K.K., the Japanese subsidiary of Bristol-Myers Squibb, has been committed to providing unprecedented, innovative medicines that can improve treatment and quality of life for patients and their families in Japan who fight against serious diseases with unmet medical needs. Please visit the Japanese website for more information:http://www.bms.com/jp

About Ono Pharmaceutical Co., Ltd.

Ono Pharmaceutical Co., Ltd., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating and developing innovative medicines in specific areas, especially in oncology and diabetes areas. For more detailed information, please visit the company's website athttp://www.ono.co.jp/eng/.

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