AbbVie receives HUMIRA orphan drug designation from FDA for treatment of non-infectious uveitis

AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) has granted 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.

Uveitis is a general term that encompasses several inflammatory eye diseases. The associated inflammation causes damage of eye tissue leading to reduced vision and/or vision loss. While the exact cause of uveitis is unknown, this condition can be caused by an infection, autoimmune disease, medication, surgery or trauma to the eye. Symptoms of uveitis may include vision loss, blurred vision, eye pain and redness, as well as sensitivity to light. It is estimated that uveitis accounts for 10 to 15 percent of all cases of total blindness in the U.S.

"Few well characterized treatment options are available for patients suffering from uveitis, and the orphan drug designation recognizes the significant unmet need that exists within this disease," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "AbbVie remains committed to the ongoing development of HUMIRA to treat a variety of autoimmune diseases where patients have the potential to benefit."



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