FDA approves adalimumab for the treatment of non-infectious uveitis

The US Food and Drug Administration (FDA) has approved AbbVie’s Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis.

Adalimumab is now the first and only FDA-approved non-corticosteroid therapy available for adults with non‑infectious intermediate, posterior and panuveitis.

Last month, the European Commission also approved adalimumab in the European Union for the treatment of non‑infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

Commenting on the approval, Mike Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie, said: “We are pleased to provide patients with the first FDA-approved non-corticosteroid treatment option for certain types of uveitis, an eye disease that can flare and impact vision. These approvals reflect our ongoing focus on continuing to innovate with Humira to address critical unmet needs of patients living with serious immune-mediated diseases.”

Adalimumab targets and helps block TNF-α

Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids. Adalimumab targets and helps block TNF-α, a specific source of inflammation that can have a role in uveitis. The FDA approval is based on results from two pivotal Phase III studies, VISUAL-I and VISUAL-II, which demonstrated that adult patients with active and controlled non-infectious intermediate, posterior and panuveitis treated with HUMIRA had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity), compared to placebo. No new safety risks were identified for adult patients with non-infectious uveitis treated with adalimumab every other week.

This approval also marks the 10th approved indication for adalimumab in the United States for immune-mediated diseases. Since its first approval in the United States more than 13 years ago, adalimumab has been approved in more than 90 countries. It is currently being used to treat more than 989,000 patients worldwide across 14 globally approved indications.