Japan approves Humira for multiple indications
Specifically, the therapy is designated for rheumatoid arthritis, psoriasis vulgaris, arthropathic psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, intestinal Behçet's disease, moderate to severe active Crohn's disease and ulcerative colitis.
AbbVie officials worked with Japanese pharmaceutical company Eisai to secure the approval of Humira in Japan from Japan's Ministry of Health, Labor and Welfare (MHLW). Humira was rigorously tested in Japan, achieving the necessary “all-case surveillance” special drug use-results survey conditions.
Humira was approved with conditions in Japan in July 2011 for treatment of polyarticular JIA.
“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,” MHLW officials said.
AbbVie will market and manufacture Humira for use in Japan; Eisai will be in charge of distribution.
Organizations in this story
AbbVie 1 N Waukegan Rd Lake Bluff, IL - 60044
Eisai 100 Tice Blvd. Woodcliff Lake, NJ - 07677