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Humira gains FDA orphan drug designation
The FDA has granted AbbVie’s adalimumab (Humira) orphan drug designation for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
North Chicago, IL-The FDA has granted AbbVie’s adalimumab (Humira) orphan drug designation for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
AbbVie is investigating the efficacy and safety of the drug for the treatment of non-infectious uveitis, which is currently in phase III development.
The drug is not currently approved to treat any form of uveitis.
“Few well-characterized treatment options are available for patients suffering from uveitis, and the orphan drug designation recognizes the signification unmet need that exists within this disease,” said Scott Brun, MD, vice president, pharmaceutical development, AbbVie. “AbbVie remains committed to the ongoing development of (the drug) to treat a variety of autoimmune diseases where patients have the potential to benefit.”
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