Thursday, May 23, 2013

AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet's Disease in Japan

AbbVie GK  and Eisai Co., Ltd.  today announced that they have received indication approval for the treatment of intestinal Behçet's disease for HUMIRA® Pre-filled Syringe 40 mg / 0.8 mL (adalimumab; recombinant, “HUMIRA”), a fully human anti-TNF-α monoclonal antibody formulation. This latest approval makes HUMIRA the first biologic to have been indicated for intestinal Behçet's disease in Japan.

Behçet's disease is a chronic, systemic inflammatory disease characterized by clinical symptoms such as recurrent aphthous stomatitis, skin manifestations, eye inflammation and genital ulcers. In Japan, the treatment of Behçet's disease is covered under the Specified Disease Treatment Research Program. As of March 2012, more than 18,000 patients with Behçet's disease had received treatment under this program. Behçet's disease accompanied by intestinal ulcer, which occurs in 10-15% of the total patients, is referred to as intestinal Behçet's disease.

HUMIRA is now indicated for seven diseases for the treatment of immune-mediated inflammatory diseases in Japan, including rheumatoid arthritis (including inhibition of structural damage), plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, and intestinal Behçet's disease.

AbbVie is the marketing and manufacturing authorization holder of HUMIRA in Japan and Eisai is responsible for its distribution. Both companies work together to help address significant unmet medical and patient needs, and provide HUMIRA as a new treatment for intestinal Behçet's disease. 



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