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news.Abbott has received approval from the Japanese Ministry of Health, Labour and Welfare for Humira for the treatment of rheumatoid arthritis in patients with inadequate response to conventional therapy.
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This approval is claimed to be the first for Humira in Japan, where Abbott co-developed and will co-market Humira with Eisai. Humira is expected to become available to patients in Japan in the coming months, following the standard pricing approval process.
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.
Glenn Warner, vice president, pharmaceuticals, Japan, Abbott, said: “The approval of Humira in Japan is a significant milestone for Abbott. This approval is both good news for Japanese patients and a significant step forward for Abbott in Japan.”