FDA Clears Adalimumab (Humira) for Uveitis

Megan Brooks

Disclosures

July 01, 2016

The US Food and Drug Administration (FDA) has approved adalimumab (Humira, AbbVie) for use in patients with noninfectious intermediate and posterior uveitis and panuveitis, the company announced.

Adalimumab is the first and only FDA-approved noncorticosteroid therapy for adults with noninfectious intermediate uveitis, posterior uveitis, and panuveitis, they said in a news release.

The approval marks the 10th approved indication for adalimumab in the United States for immune-mediated diseases, including psoriatic arthritis, ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, Crohn's disease, hidradenitis suppurativa, ulcerative colitis, and chronic plaque psoriasis.

The FDA approval is based on results from two phase 3 studies, which showed that adults with active and controlled noninfectious intermediate and posterior uveitis and panuveitis treated with adalimumab every other week had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity) compared with placebo. No new safety risks were identified in this patient population.

The European Commission recently approved adalimumab in the European Union for noninfectious intermediate and posterior uveitis and panuveitis in adult patients who do not respond adequately to corticosteroids, in patients who need corticosteroid-sparing, or patients in whom corticosteroid treatment is inappropriate.

"These approvals provide a valuable option for patients experiencing flare and vision impairment associated with this group of inflammatory diseases of the eye," Glenn J. Jaffe, MD, Duke University, Durham, North Carolina, said in the release. "Data from the robust VISUAL clinical trial program demonstrate the value of Humira as a treatment option for patients with these serious diseases."

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