The US Food and Drug Administration has approved AbbVie's Humira for the treatment of non-infectious intermediate, posterior and panuveitis, marking its 10th green light in the country for an immune-mediated disease.
With the approval Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with non‑infectious intermediate, posterior and panuveitis, a group of inflammatory conditions of the eye that can flare and impair vision.
Humira targets and helps block TNF-α, a specific source of inflammation that can have a role in uveitis.
Regulatory clearance comes on the back of data from two pivotal Phase III studies, VISUAL-I and VISUAL-II, which showed that adults with active and controlled non-infectious intermediate, posterior and panuveitis treated with the drug had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity), compared to placebo.
US approval comes hot on the heels of a nod from European regulators, which cleared its use in adult patients who have failed to respond to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.