Wednesday, April 16, 2008

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(R) (adalimumab) for the treatment of RA (Rheumatoid Arthritis)in patients with inadequate response to conventional therapy. Abott and Eisai has codeveloped this product and will market jointly. HUMIRA is now approved in 75 countries for RA 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.

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, who was involved in the development of HUMIRA for the treatment of RA 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.

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