AbbVie announced that the Food and Drug Administration (FDA) has approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior, and panuveitis. This approval marks the first non-corticosteroid treatment approved for adults with non-infectious intermediate, posterior, and panuveitis.
Non-infectious uveitis is an immune-mediated disease that can flare and impair vision. Humira works by targeting and blocking tumor necrosis factor alpha (TNF-α), a source of inflammation that can play a role in uveitis. The approval was based on data from two Phase 3 studies, VISUAL-I and VISUAL-II, which showed that adults with active and controlled non-infectious intermediate, posterior, and panuveitis treated with Humira had a significantly reduced risk for treatment failure vs. placebo (hazard ratio [HR] 0.5, 95% CI: 0.36–0.70; P<0.001). Treatment failure was defined as a combination of uveitic flare and decrease in visual activity.
The median time to treatment failure in VISUAL-I was extended by 87% in those treated with Humira. In VISUAL-II, the median time to treatment failure was 8.3 months for the placebo group vs. >18 months (not estimable) for the Humira group, as over half of these patients did not experience treatment failure (HR 0.57, 95% CI: 0.39–0.84; P=0.004). Also, no new safety risks were reported among adults treated with Humira every other week.
The FDA granted Humira an orphan drug designation for the treatment of certain forms of uveitis in 2014. Humira is already indicated for use in various arthritis/rheumatic disorders, colorectal disorders, psoriasis, and hidradenitis suppurativa. It is available as 10mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL solution for subcutaneous (SC) injection.
For more information call (800) 633-9110 or visit Humira.com.