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AbbVie June 30th

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    This was out on June 30th. RRM

    AbbVie's HUMIRA® (adalimumab) Receives U.S. Food and Drug Administration Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis
    - Non-infectious uveitis is an immune-mediated disease that can flare and impair vision
    - HUMIRA is now the first and only FDA-approved non-corticosteroid therapy for non-infectious intermediate, posterior and panuveitis
    - Approval marks the 10th approved indication for HUMIRA in the United States and follows recent European Commission marketing authorization for this indication
    - In 2014, FDA granted HUMIRA orphan drug designation for the treatment of certain forms of non-infectious uveitis
    NORTH CHICAGO, Ill., June 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved 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 non‑infectious intermediate, posterior 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 non‑infectious 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-α, a specific source of inflammation that can have a role in uveitis.1,2 The FDA approval is based on results from two pivotal Phase 3 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.3
    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 non‑infectious intermediate, posterior 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 currently being used to treat more than 989,000 patients worldwide4 across 14 globally approved indications and 10 U.S. approved indications.3,5,6
 
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