The FDA has approved Humira (adalimumab) for the treatment of noninfectious intermediate and posterior uveitis and panuveitis, AbbVie has announced. Humira is now the first and only FDA-approved noncorticosteroid therapy available for adults with noninfectious intermediate and posterior uveitis and panuveitis. This approval marks the 10th approved indication for Humira in the United States for immune-mediated diseases.
This month, the European Commission also approved Humira in the European Union for the treatment of noninfectious intermediate and posterior uveitis and panuveitis in adults who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.
Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids. Humira targets and helps block tumor necrosis factor-alpha, a specific source of inflammation that can have a role in uveitis. The FDA approval is based on results from two pivotal phase 3 studies, VISUAL-I and VISUAL-II, which demonstrated that adults with active and controlled noninfectious intermediate and posterior uveitis and panuveitis treated with Humira had a significantly lower risk for treatment failure (a combination of uveitic flare and decreased visual acuity), compared with placebo. No new safety risks were identified for adults with noninfectious uveitis treated with Humira every other week.
The trials investigated active and controlled noninfectious intermediate and posterior uveitis and panuveitis. Both trials were double-masked, randomized, and placebo-controlled. VISUAL-I and VISUAL-II were randomized 1:1, and patients treated with Humira received an 80-mg baseline loading dose followed by 40 mg given by subcutaneous injection at week 1, followed by 40 mg every other week for up to 80 weeks. The primary endpoint in the VISUAL-I and VISUAL-II studies was time to treatment failure (TF), defined as having one or more of the following components present in at least one eye: increase in anterior chamber cells or vitreous haze, new chorioretinal or vascular lesions, or decrease in visual acuity.
The VISUAL-I study found that, compared with placebo, patients on Humira were significantly less likely to experience TF (hazard ratio [HR], 0.5; 95% confidence interval [CI], 0.36–0.70; P < 0.001). Median time to TF was prolonged by 87%, from three months for placebo to 5.6 months for Humira. In the VISUAL-II study, the median time to TF was 8.3 months for placebo and not estimable (more than 18 months) for Humira, as more than half of the Humira-treated patients did not experience TF (HR, 0.57; 95% CI, 0.39–0.84; P = 0.004).
In 2014, the FDA granted Humira orphan drug designation for the treatment of certain forms of uveitis, which affect a population of fewer than 200,000 patients. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of noninfectious intermediate and posterior uveitis and panuveitis in adult patients.
Since its first approval in the United States more than 13 years ago, Humira has been approved in more than 90 countries. It is being used to treat more than 989,000 patients worldwide across 14 globally approved indications and 10 U.S. approved indications.
Source: AbbVie; June 30, 2016.