AbbVie gains FDA orphan designation for Humira in uveitis

21 May 2014

The US Food and Drug Administration granted US drugmaker AbbVie’s (NYSE: ABBV) blockbuster rheumatoid arthritis drug Humira (adalimumab) orphan drug designation for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis, a group of rare but serious inflammatory diseases of the eye.

AbbVie is investigating the efficacy and safety of Humira for the treatment of non-infectious uveitis, and the clinical program is in Phase III development. Humira is not currently approved to treat any form of uveitis. The drug is already marketed for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic plaque psoriasis, generating annual sales of around $10.7 billion last year and making Humira the top-selling drug worldwide.

Significant unmet need for uveitis

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