TOKYO, June 21, 2018 – AbbVie GK (Headquarters: Tokyo, President: James Feliciano, “AbbVie”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that HUMIRA® for Subcutaneous Injection 20 mg Syringe 0.2 mL, a new pediatric formulation of HUMIRA ® (generic name: adalimumab [recombinant], “HUMIRA”), a fully human anti-TNF-α 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.