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Humira Wins FDA Nod for Uveitis

— 10th approved indication for adalimumab

MedpageToday

The FDA has approved adalimumab (Humira) for certain types of uveitis, .

Patients with non-infectious intermediate, posterior, and panuveitis may be treated with the biologic drug, a tumor necrosis factor inhibitor given every other week by subcutaneous injection.

It's the first nonsteroidal treatment to be approved for these forms of uveitis, AbbVie said.

The firm evaluated the drug's safety and efficacy in two phase III trials, in which the rates of treatment failure -- defined as a combination of uveitic flare and loss of visual acuity -- were reduced by about half compared with placebo. In one of the studies, median time to treatment failure was about doubled to 5.6 months; in the other, no median was reached by 18 months with adalimumab. Safety issues were the same as have been seen in other indications.

Adalimumab was previously approved for nine other conditions, including rheumatoid arthritis, inflammatory bowel disease, psoriasis, and hidradenitis suppurativa.