AbbVie, a global biopharmaceutical company, announced that the US 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-a, 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.
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 worldwide across 14 globally approved indications and 10 US approved indications.
The pivotal clinical trials investigated active and controlled non-infectious intermediate, posterior and panuveitis. Both trials were double-masked, randomized and placebo-controlled. VISUAL-I and VISUAL-II clinical trials were randomized 1:1 and patients treated with Humira received an 80 mg baseline loading dose followed by 40 mg given by subcutaneous injection at week 1, followed by 40 mg every other week for up to 80 weeks. The primary endpoint in the VISUAL-I and VISUAL-II studies was time to treatment failure (TF), defined as having one or more of the following components present in at least one eye: increase in anterior chamber cells or vitreous haze, new chorioretinal or vascular lesions, or decrease in visual acuity.
The VISUAL-I study found that, compared to placebo, patients on Humira were significantly less likely to experience TF (hazard ratio=0.5; 95 percent CI, 0.36–0.70; P<0.001). Median time to TF was prolonged by 87 percent, from 3 months for placebo to 5.6 months for Humira. In the VISUAL-II study, the median time to TF was 8.3 months for placebo and not estimable (>18 months) for Humira, as more than half of the Humira-treated patients did not experience TF (hazard ratio=0.57; 95% Cl, 0.39-0.84; P=0.004).
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.
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, help get moderate to severe ulcerative colitis (UC) under control (induce remission) in adults and keep it under control (sustain remission) when certain other medicines have not worked well enough.