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FDA approves Humira for treatment of noninfectious intermediate, posterior and panuveitis
The FDA has approved Humira for the treatment of noninfectious intermediate and posterior uveitis and panuveitis, according to a press release from AbbVie.
With this approval, the company now has 10 approved indications for Humira (adalimumab) in the U.S. for immune-mediated diseases.
In June, the European Commission approved Humira for the treatment of noninfectious intermediate and posterior uveitis and panuveitis. In the U.S., this is the first non-corticosteroid treatment available for these indications.
The approval was based on the phase 3 VISUAL-I and VISUAL-II studies, which showed adult patients with noninfectious intermediate and posterior uveitis and panuveitis treated with Humira had a significantly lower risk of uveitic flare and decreased visual acuity compared with placebo.