The FDA has approved AbbVie’s Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with noninfectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for Humira in the U.S. for immune-mediated diseases.
This month, the European Commission also approved Humira in the E.U. for the treatment of noninfectious 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.
"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," said Mike Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "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."
"These approvals provide a valuable option for patients experiencing flare and vision impairment associated with this group of inflammatory diseases of the eye," said Glenn J. Jaffe, M.D., Duke University, Durham, N.C. "Data from the robust VISUAL clinical trial program demonstrate the value of Humira as a treatment option for patients with these serious diseases."
Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids. Humira targets and helps block TNF-, 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 Humira every other week.
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, posterior and panuveitis in adult patients.
Since its first approval in the U.S. more than 13 years ago, Humira 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 and 10 U.S. approved indications.
The pivotal clinical trials investigated active and controlled non-infectious intermediate, posterior and panuveitis. Both trials were double-masked, randomized and placebo-controlled. VISUAL-I and VISUAL-II clinical trials were randomized 1:1 and patients treated with HUMIRA received an 80mg baseline loading dose followed by 40mg given by subcutaneous injection at week one, followed by 40mg 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 to placebo, patients on HUMIRA were significantly less likely to experience TF (hazard ratio=0.5; 95% CI, 0.360.70; 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 (>18 months) for HUMIRA, as more than half of the HUMIRA-treated patients did not experience TF (hazard ratio=0.57; 95% Cl, 0.39-0.84; P=0.004).