AbbVie and Eisai Announce the Launch of HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL

Product name:AbbVie and Eisai Announce the

2018/06/22 update

Industry:HealthCare

A New Pediatric Formulation of HUMIRA

TOKYO, Jun 21, 2018 - (JCN Newswire) - AbbVie GK and Eisai Co., Ltd. announced that HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL, a new pediatric formulation of HUMIRA (generic name: adalimumab [recombinant]), a fully human anti-TNF-alpha monoclonal antibody formulation, has been launched today after being listed in the National Health Insurance reimbursement price list on June 15.

HUMIRA has an indication of "treatment of polyarticular juvenile idiopathic arthritis (JIA)" that develops in pediatric patients.

HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is a higher-concentration formulation, which is produced by removing some excipients, and has the same active ingredient as that of, HUMIRA for Subcutaneous Injection 20 mg Syringe 0.4 mL that has been commercially available since September 2011. It has also the same formulation and concentration as those of HUMIRA for Subcutaneous Injection 40 mg Syringe 0.4 mL and HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL that were launched in November 2016. Outside of Japan, two phase 2, randomized, single- blind, two-period crossover studies were conducted with HUMIRA for Subcutaneous Injection 40 mg Syringe 0.4 mL, to compare injected site-related pain between this higher- concentration formulation and the former formulation, using a visual analog scale (VAS). Patients with rheumatoid arthritis showed a significantly lower VAS pain score after injection of the higher- concentration formulation, as compared with the former formulation.

JIA is an autoimmune disease that generally affects children under 16 years of age and is an umbrella term used to define a group of conditions occurring among children that include some form of chronic arthritis. In Japan, JIA affects 10-15 persons per 100,000 children, and is designated as an incurable disease by the Ministry of Health, Labour and Welfare. Polyarticular JIA is a type of JIA which involves five or more joints. Symptoms include painful and swollen joints, limping, morning stiffness, decreased activity and the reluctance to use an arm or leg.
AbbVie and Eisai will continue to promote and provide information on the proper use of HUMIRA while making further contributions to improve the quality of life of patients including children.

About HUMIRA

HUMIRA is a fully human anti-TNF-alpha monoclonal antibody formulation. In Japan, it is approved for the indications of "the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage), the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis*, intestinal Behcet's disease, and non-infectious uveitis, posterior uveitis or panuveitis, induction and maintenance therapy for moderate to severely active Crohn's disease (limited to patients who have had an inadequate response to conventional therapy), and treatment of moderate to severe ulcerative colitis (limited to patients who have had an inadequate response to conventional therapy ).

*HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved for this indication.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com.

About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Public Affairs Division
AbbVie GK Public Relations Department
+81-(0)3-4577-1112

Eisai Co., Ltd.
+81-(0)3-3817-5120
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