Abbott’s Humira, Approved in Japan

April 21, 2008 by  
Filed under ARTHRITIS

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First it was Roche’s Actimra, now it is Abbott’s Humira that’s been approved in Japan.

The Japanese Ministry of Health, Labour and Welfare has approved Humira for the treatment of rheumatoid arthritis (RA) in patients with inadequate response to conventional therapy.

“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.

This Humira approval is the first for Abbot in Japan, wherein Abbott co-developed and will co-market HUMIRA with Eisai Co., Ltd. At present HUMIRA is already approved in 75 countries for rheumatoid arthritis and other autoimmune disease indications.

“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.

In the United States and Europe, Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn′s disease and plaque psoriasis (Ps).

HUMIRA is also approved for the treatment of juvenile idiopathic arthritis (JIA) in the United States, and review for JIA in Europe is ongoing. Clinical trials are underway evaluating the potential of HUMIRA in ulcerative colitis. To date, HUMIRA has been approved in 75 countries and more than 250,000 people worldwide are currently being treated with HUMIRA.

HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-α), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

Well, it is indeed great the RA drugs such as Humira is making it to Asia, maybe in time this be readily available (by prescription of course!) here in the Philippines.

Read the full press release from Abbott.

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