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AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis

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

About VISUAL-I and VISUAL-II

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.3 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).3

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1 Brezin AP, Kestelyn P, Van Calster J, Jaffe GJ, Thorne JE, Scales D, Franco P, Dick AD, Nguyen QD, Suhler EB, Camez A, Song AP, Kron M, Tari S, Rosenbaum JT, Heiligenhaus A. Adalimumab in Patients with Active, Noninfectious Uveitis Using High-Dose Corticosteroids [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/adalimumab-in-patients-with-active-noninfectious-uveitis-using-high-dose-corticosteroids/. Accessed May 26, 2016.
2 Nguyen QD, Kurup SK, Merrill P, Sheppard J, Van Calster J, Dick AD, Jaffe G, Mackensen F, Rosenbaum JT, Schlaen A, Camez A, Tari S, Kron M, Song A, Brezin A. Adalimumab in Patients with Inactive, Non-Infectious Uveitis Requiring Systemic Treatment [abstract]. Arthritis Rheumatol. 2015; 67(suppl 10). http://acrabstracts.org/abstract/adalimumab-in-patients-with-inactive-non-infectious-uveitis-requiring-systemic-treatment/. Accessed May 26, 2016.
3 HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
4 Data on File ABVRRTI62403.
5 HUMIRA [Summary of Product Characteristics]. AbbVie Ltd. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&murl=menus/medicines/ medicines.jsp&mid=WC0b01ac058001d124. Last updated June 16, 2016. Accessed June 29, 2016.
6 Pharmaceutical and Medical Devices Agency (PMDA) website. New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed June 29, 2016.

SOURCE AbbVie

Posted: June 2016

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