AbbVie and Eisai Clear All-Case Surveillance Condition for Approval of HUMIRA, a Fully Human Anti-TNF-α Monoclonal Antibody, in the Treatment of Polyarticular Juvenile Idiopathic Arthritis

・Japan's Ministry of Health, Labour and Welfare cleared the condition for approval based on a review of an interim report of all-case surveillance on patients with polyarticular juvenile idiopathic arthritis
・The analysis results supported the previously established safety and efficacy of HUMIRA(R)

AbbVie GK (Headquarters: Tokyo, President: James C. Feliciano, "AbbVie") and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that they have received notification from Japan's Ministry of Health, Labour and Welfare (MHLW) to the effect that the "all-case surveillance" special drug use-results survey condition required for approval of HUMIRA(R) Pre-filled Syringe 20 mg / 0.4 mL and HUMIRA(R) Pre-filled Syringe 40 mg / 0.8 mL (adalimumab; [genetical recombination], "HUMIRA(R)"), a fully human anti-TNF-α monoclonal antibody formulation, has been lifted for use in patients with polyarticular juvenile idiopathic arthritis (JIA).

In July 2011, the MHLW approved the indication of polyarticular JIA for HUMIRA® with the following condition for approval: "Because of the very limited number of subjects treated in the Japanese clinical trials, the applicant is required to conduct all-case drug use-results survey until data from a certain number of patients are accumulated after market launch, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product."

The MHLW lifted this condition for approval based on a review of requirements in the approval condition for HUMIRA(R), i.e., early collection of the safety and efficacy data on HUMIRA(R) and necessary measures for its proper use, which were submitted to the MHLW in an interim report of the all-case surveillance in 176 patients with polyarticular JIA. The analysis results supported the previously established safety and efficacy of HUMIRA(R). Adverse drug reactions developed in 30.1% of patients (53 of 176), and regarding efficacy, the results observed in the survey were similar to that observed in other clinical studies conducted in Japan to date.

Clinical studies of HUMIRA(R) have been carried out extensively to date and a wide literature of clinical data exists on the drug. In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA®, while Eisai is responsible for distribution. The two companies are working together to promote the product under a one-brand, one-channel, two-promotion scheme.
 
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.

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