Abbott Laboratories (ABBOTT PARK, Illinois) announced that it has received approval from the Japanese Ministry of Health, Labour, and Welfare for Humira^® (adalimumab) to treat rheumatoid arthritis (RA) in patients with inadequate response to conventional therapy. The approval is the first for the drug in Japan, where Abbott codeveloped and will comarket it with Eisai Co, Ltd. Humira will be available to patients in Japan in the coming months, following the standard pricing approval process.

In addition, Abbott has submitted an application for approval of Humira for plaque psoriasis, and is codeveloping and marketing the drug with Eisai in Japan for Crohn's disease, ankylosing spondylitis, juvenile RA, and ulcerative colitis.

Humira, a TNF-α blocking agent, is the only fully human monoclonal antibody approved to treat RA, psoriatic arthritis, ankylosing spondylitis, Crohn′s, and plaque psoriasis in the US and Europe. The drug is also approved to treat juvenile idiopathic arthritis (JIA) in the US; a review for JIA in Europe is ongoing. Clinical trials are underway evaluating the potential of the drug in ulcerative colitis. To date, Humira has been approved in 75 countries and >250,000 people worldwide are being treated with the drug.