4 Jul 2016

AbbVie’s HUMIRA® (adalimumab) got USFDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis

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AbbVie, 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.

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. 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.

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.

HUMIRA is a prescription medicine used:
•To reduce the signs and symptoms of: ◦Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.

Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
Ankylosing spondylitis (AS) in adults.
Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
Moderate to severe hidradenitis suppurativa (HS) in adults.

•In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.

•To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

•To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.