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The FDA has granted AbbVie orphan drug status for Humira (adalimumab) to speed its testing as a treatment for noninfectious uveitis.
The pharmaceutical firm AbbVie has announced that it has received orphan drug status from the Food and Drug Administration to investigate development of its drug Humira (adalimumab) as a treatment for several forms of non-infectious uveitis.
Orphan drug status enables incentives such as tax credits, grant funding and assistance for development of clinical trials, and seven-year exclusive marketing rights, to encourage development of drugs for rare conditions.
The incidence of uveitis is approximately 50/100,000. It is a common extra-articular manifestation of autoimmune disorders such as psoriatic arthritis and ankylosing spondylitis. For instance, a population-based study from the Netherlands published recently in Annals of the Rheumatic Diseases found that acute anterior uveitis develops in more than 11% of patients with ankylosing spondylitis.
Adalimumab has been found effective for noninfectious uveitis in numerous clinical trials.