Abbott Announces HUMIRA® (adalimumab) Approved in Japan for the Treatment of Rheumatoid Arthritis

Abbott announced today that it has received approval from the Japanese Ministry of Health, Labour and Welfare for HUMIRA® (adalimumab) for the treatment of rheumatoid arthritis in patients with inadequate response to conventional therapy. This approval is the first for HUMIRA in Japan, where Abbott co-developed and will co-market HUMIRA with Eisai Co., Ltd. HUMIRA is now approved in 75 countries for rheumatoid arthritis and other autoimmune disease indications.

“The approval of HUMIRA in Japan is a significant milestone for Abbott,” said Glenn Warner, vice president, Pharmaceuticals, Japan, Abbott. “This approval is both good news for Japanese patients and a significant step forward for Abbott in Japan.”

HUMIRA is expected to become available to patients in Japan in the coming months, following the standard pricing approval process.

“The clinical studies of HUMIRA in Japanese patients demonstrated the efficacy and safety of this medicine,” said Prof. Nobuyuki Miyasaka, M.D., Department of Collagen Disease and Rheumatology, Tokyo Medical and Dental University Graduate School of Medicine, who was involved in the development of HUMIRA for the treatment of rheumatoid arthritis in Japan.

Abbott has submitted an application for approval of HUMIRA for plaque psoriasis, and is also developing HUMIRA in Japan for Crohn’s disease, ankylosing spondylitis, juvenile rheumatoid arthritis and ulcerative colitis. Eisai is co-developing and will jointly market these indications with Abbott.