AbbVie Receives CHMP Positive Opinion for HUMIRA® (adalimumab) for the Treatment of Pediatric Patients with Chronic Non-infectious Anterior Uveitis

NORTH CHICAGO, Ill., July 21, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

"Today's positive CHMP opinion marks a significant milestone for pediatric uveitis patients and their caregivers," said Marek Honczarenko, vice president, immunology development. "When HUMIRA's label is expanded to include chronic non-infectious anterior uveitis it will provide an important new treatment option for children from two years of age living with this serious and potentially blinding condition, especially for those patients who have failed standard treatments. It is also a reflection of AbbVie's commitment to provide therapies for both adult and pediatric patients living with immune-mediated diseases."

Uveitis is an inflammation of the uvea, which includes the iris, choroid, and the ciliary body in the eye.[2] If left untreated, it can lead to vision loss, including cataracts, glaucoma and cystoid macular edema (CME).[3], [4] Severe vision loss has been estimated to occur in 25 to 30 percent of pediatric uveitis cases, making early diagnosis and treatment essential to preserve vision in children with the disease.[3], [5] JIA is the most common systemic disorder associated with uveitis in children accounting for more than 75 percent of cases of pediatric anterior uveitis.[1]

"Childhood uveitis is a challenging condition often associated with delays in diagnosis and high morbidity," said Professor Athimalaipet Ramanan, pediatric rheumatologist at University Hospitals Bristol NHS Trust and principal investigator of the SYCAMORE study. "The clinical trial data demonstrate that HUMIRA has the potential to help thousands of children preserve their eyesight from the ocular complications associated with chronic non-infectious anterior uveitis."

The CHMP opinion is based on results from the SYCAMORE clinical trial, a randomized controlled study of the clinical effectiveness and safety of HUMIRA combined with methotrexate versus methotrexate plus placebo for the treatment of active JIA-associated uveitis.[6]  It was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. The Independent Data Safety and Monitoring Committee (IDSMC) recommended unmasking the trial early after 90 randomized patients with active JIA-associated uveitis showed that HUMIRA combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure than placebo.[6]

The review of the marketing authorization application (MAA) is being conducted under the centralized licensing procedure. A marketing authorization decision is anticipated by September. If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. HUMIRA was approved by the European Medicines Agency (EMA) for the treatment of non-infectious intermediate, posterior and panuveitis in adults in June 2016.

About the SYCAMORE Trial[6]
The SYCAMORE clinical trial was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. The study was supported by grants from the National Institute for Health Research Health Technology Assessment Programme and Arthritis Research UK. In this multicenter, double-masked, randomized, placebo-controlled trial, researchers assessed the efficacy and safety of HUMIRA in children and adolescents two years of age or older who had active JIA-associated uveitis. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either HUMIRA (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every two weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. They were followed for up to two years after randomization. The primary endpoint was the time to treatment failure, defined according to multiple components of intraocular inflammation that was based on the Standardization of Uveitis Nomenclature (SUN) criteria.[6]

Study results showed that the addition of HUMIRA to methotrexate significantly delayed the time to treatment failure as compared with placebo and the pre-specified stopping criteria were met after the enrollment of 90 of 114 patients. Researchers observed 16 treatment failures in 60 patients (27 percent) in the HUMIRA group versus 18 treatment failures in 30 patients (60 percent) in the placebo group (hazard ratio, 0.25; 95 percent confidence interval [CI], 0.12 to 0.49; P<0.0001 [the pre-specified stopping boundary]). Adverse events were reported more frequently in patients receiving HUMIRA than in those receiving placebo (10.07 events per patient-year [95 percent CI, 9.26 to 10.89] vs. 6.51 events per patient-year [95 percent CI, 5.26 to 7.77]), as were serious adverse events (0.29 events per patient-year [95 percent CI, 0.15 to 0.43] vs. 0.19 events per patient-year [95 percent CI, 0.00 to 0.40]).

About HUMIRA in the European Union[7] 

HUMIRA EU Therapeutic Indications[7]
HUMIRA is approved for use in adults with moderate to severe active and progressive 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 non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in adults and adolescents from 12 years of age with active moderate to severe hidradenitis suppurativa, and in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indications.

Important EU Safety Information
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.

Globally, prescribing information varies; refer to the individual country product label for complete information.

(See SmPC for full safety details)

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

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," in AbbVie's 2016 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] Palejwala, N.V., Yeh, S. & Angeles-Han, S.T. Current Perspectives on Ophtalmic Manifestations of Childhood Rheumatic Diseases. Curr Rheumatol Rep (2013) 15: 341. doi:10.1007/s11926-013-0341-3

[2] Sen E.S., Dick A.D., Ramanan A.V. Uveitis associated with juvenile idiopathic arthritis. Nat Rev Rheumatol. 2015;11:338–348.

[3] Cunningham E.T. Jr. Uveitis in children. Ocul Immunol and Inflamm. 2000;8:251–261.

[4] Smith J.A., Mackensen F., Sen H.N., et al. Epidemiology and course of disease in childhood uveitis. Ophthalmology. 2009 Aug;116(8):1544-1551.

[5] Bhat, P.V., MD; Goldstein, D.A., MD. Pediatric Anterior Uveitis. Available at: https://www.aao.org/pediatric-center-detail/pediatric-anterior-uveitis. Accessed July 13, 2017

[6] Ramanan, A.V., F.R.C.P.C.H., F.R.C.P., Dick, A.D., M.B., B.S., M.D., et.al. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017;376:1637-46.

[7] HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated March 31, 2017. Accessed April 24, 2017.

SOURCE AbbVie

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