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Press Release

AbbVie and Eisai Obtain Additional Approval for New Indication of Fully Human Anti-TNF-alpha Monoclonal Antibody HUMIRA in the Treatment of non-infectious Uveitis

Posted on: 29 Sep 16

TOKYO, Sept 28, 2016 - (JCN Newswire) - AbbVie GK and Eisai Co., Ltd. today announced the additional approval for a new indication of HUMIRA (generic name: adalimumab [recombinant]), a fully human anti-TNF-alha monoclonal antibody formulation, in the treatment of non-infectious intermediate, posterior and panuveitis. Through this approval, HUMIRA has become the first biologic treatment available for non-infectious intermediate, posterior and panuveitis regardless of underlying disease.

Non-infectious uveitis is a group of diseases characterized by inflammation of the uvea, the middle layer of the eye.(1) It can lead to reduced vision or vision loss and is the third-leading cause of preventable blindness worldwide.(1-5) However, non-infectious uveitis can be complicated to diagnose and treat(6,7) and there are no universally accepted guidelines for the treatment of the condition.(8,9) At this time, corticosteroids are the current mainstay of treatment in uveitis patients excluded infectious condition.(10) However, they may not be effective in all patients, and can have serious ocular long-term side effects including glaucoma and cataracts.(11,12) Some patients have underlying diseases that preclude the use of corticosteroids.

HUMIRA targets and helps block TNF-alpha, a specific source of inflammation that can have a role in uveitis.(13,14) The approval is based on results from two pivotal Phase 3 studies VISUAL-I and VISUAL-II, and also extension study VISUAL-III, which demonstrated that patients with active and controlled noninfectious intermediate, posterior and panuveitis treated with HUMIRA had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity), compared to placebo. No new safety risks were identified for patients with non-infectious uveitis treated with HUMIRA.(15)

In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA, while Eisai is responsible for distribution. In addition to the new indication of non-infectious uveitis, Abbvie and Eisai are co-promoting HUMIRA for the indications in rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis. For the indications in the field of gastrointestinal disease such as ulcerative colitis, Crohn's disease, and intestinal Bechet's disease, AbbVie and EA Pharma, a subsidiary of Eisai, are co-promoting HUMIRA.

AbbVie and Eisai will continue to promote and provide information on the proper use of HUMIRA while making further contributions to improve the quality of life of patients with non-infectious uveitis.

Editor's Details

Mike Wood

Last updated on: 29/09/2016

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