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AbbVie receives positive opinion in Europe for Humira as treatment for noninfectious uveitis
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AbbVie has received a positive opinion from the Committee for Medicinal Products for Human Use for Humira as a treatment for noninfectious uveitis, according to a company press release.
If approved by the European Commission, Humira (adalimumab) “would be the first biologic treatment option offered in the European Union for certain patients with noninfectious intermediate, posterior and panuveitis,” the release said.
The opinion was based on two double-masked, randomized, placebo-controlled clinical trials, VISUAL I and VISUAL II, which investigated active and noninfectious intermediate, posterior and panuveitis in adults. In both trials, patients who received Humira experienced a significantly lower rate of uveitic flare or decrease in visual acuity compared to those receiving placebo, according to the release.
The review of the marketing authorization application for approval by the European Commission is underway.