"Today's CHMP opinion marks a key milestone towards HUMIRA becoming the first approved biologic medication for uveitis, an inflammatory condition of the eye that can impact vision," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Current treatment options are limited and sometimes ineffective. Building on more than 18 years of clinical experience with HUMIRA across indications, we hope to make an impact on the lives of more patients with unmet needs."
"With limited treatment options for non-infectious uveitis, this recommendation is a step toward progress for people living with a disease that has potentially profound effects on vision," said Glenn J. Jaffe, M.D., professor of ophthalmology, Robert Machemer M.D. professor of ophthalmology and chief, Division of Retinal Ophthalmology, at Duke University, Durham, N.C. "The data from the VISUAL clinical trial program demonstrate the safety and efficacy profile of HUMIRA in patients living with particular forms of non-infectious uveitis."
Non-infectious uveitis can be complicated to diagnose and treat6,7 and there are no universally accepted guidelines for the treatment of the condition.8,9 At this time, corticosteroids are the current mainstay of treatment after underlying conditions, such as infection, are ruled out.10 However, they may not be effective in all patients, and can have serious ocular long-term side effects including glaucoma and cataracts.11,12 Some patients have underlying diseases that preclude the use of corticosteroids.
HUMIRA targets and helps block TNF-α, a specific source of inflammation that can have a role in uveitis.13,14 The CHMP opinion is based on results from two pivotal Phase 3 studies, VISUAL-I and VISUAL-II, which demonstrated that patients with active and controlled non-infectious intermediate, posterior and panuveitis treated with HUMIRA had a significantly lower risk for uveitic flare or decrease in visual acuity, compared to placebo. The safety profile for patients with uveitis treated with HUMIRA every other week was consistent with the known safety profile of HUMIRA.13,14
The review of the marketing authorization application (MAA) is being conducted under the centralized licensing procedure. Once approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
Since first gaining marketing authorization 13 years ago, HUMIRA has been approved in more than 90 countries. It is currently being used to treat more than 989,000 patients worldwide15 across 13 globally approved indications.16,17
About VISUAL-I and VISUAL-II
The pivotal clinical trials investigated active and inactive 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 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). To be considered a TF, any 1 of these 4 criteria needed to be present in at least one eye: new lesions, anterior chamber (AC) cell grade, vitreous haze and visual acuity.13,14
The VISUAL-I study found that compared to placebo, patients on HUMIRA were 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 (PBO) to 5.6 months for HUMIRA.13 In the VISUAL-II study, the median time to TF was 8.3 months for placebo (PBO) and not estimable for adalimumab (ADA), as more than half of the ADA-treated patients did not experience TF (hazard ratio=0.57; 95% Cl, 0.39-0.84; P=0.004). No significant differences were observed between serious adverse events (SAEs), serious infections and the overall rate of adverse events (AEs) between HUMIRA and placebo.14
HUMIRA EU Therapeutic Indications16
HUMIRA is approved for use in adults with moderate to severe active rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and active moderate to severe hidradenitis suppurativa. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indication.
Important EU Safety Information16
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.
(See SmPC for full details)
Globally, prescribing information varies; refer to the individual country product label for complete information.
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. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
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, the likelihood that the transaction is consummated, the expected benefits of the transaction, 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.
* At each visit, subjects were to undergo refraction and the result of refraction for each eye was to be recorded on the electronic case report form. Using the appropriate corrective lenses based on that visit's refraction, subject's best corrected visual acuity (BCVA) was to be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart, which was provided by AbbVie if necessary.
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13 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 April 26, 2016.
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15 Data on File ABVRRTI62403.
16 HUMIRA [Summary of Product Characteristics]. AbbVie Ltd. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/000481/WC500050870.pdf. Last updated January 28, 2016. Accessed April 26, 2016.
17 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 April 26, 2016.
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