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NORTH CHICAGO, Ill., July 21, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a all-around biopharmaceutical company, appear today that the European Committee for Medicinal Articles for Human Use (CHMP) of the European Medicines Agency has accepted a absolute assessment for HUMIRA® (adalimumab) for the analysis of abiding non-infectious antecedent uveitis in pediatric patients from two years of age who accept had an bare acknowledgment to or are antipathetic to accepted therapy, or in whom accepted analysis is inappropriate.

TREMFYA® (guselkumab) Patient Support | HCP - humira patient enrollment form
TREMFYA® (guselkumab) Patient Support | HCP – humira patient enrollment form | humira patient enrollment form

“Today’s absolute CHMP assessment marks a cogent anniversary for pediatric uveitis patients and their caregivers,” said Marek Honczarenko, carnality president, immunology development. “When HUMIRA’s characterization is advertisement to accommodate abiding non-infectious antecedent uveitis it will accommodate an important new analysis advantage for accouchement from two years of age alive with this austere and potentially blinding condition, abnormally for those patients who accept bootless accepted treatments. It is additionally a absorption of AbbVie’s charge to accommodate therapies for both developed and pediatric patients alive with immune-mediated diseases.”

Uveitis is an deepening of the uvea, which includes the iris, choroid, and the ciliary anatomy in the eye.[2] If larboard untreated, it can beforehand to eyes loss, including cataracts, glaucoma and cystoid macular edema (CME).[3], [4] Astringent eyes accident has been estimated to activity in 25 to 30 percent of pediatric uveitis cases, authoritative aboriginal analysis and analysis capital to bottle eyes in accouchement with the disease.[3], [5] JIA is the best accepted systemic ataxia associated with uveitis in accouchement accounting for added than 75 percent of cases of pediatric antecedent uveitis.[1]

“Childhood uveitis is a arduous activity about associated with delays in analysis and aerial morbidity,” said Professor Athimalaipet Ramanan, pediatric rheumatologist at University Hospitals Bristol NHS Trust and arch investigator of the SYCAMORE study. “The analytic balloon abstracts authenticate that HUMIRA has the abeyant to advice bags of accouchement bottle their apparition from the ocular complications associated with abiding non-infectious antecedent uveitis.”

The CHMP assessment is based on after-effects from the SYCAMORE analytic trial, a randomized controlled abstraction of the analytic capability and assurance of HUMIRA accumulated with methotrexate against methotrexate additional placebo for the analysis of alive JIA-associated uveitis.[6]  It was sponsored by the University Hospitals Bristol NHS Foundation Trust and accommodating by the Analytic Trials Analysis Centre at the University of Liverpool. The Independent Abstracts Assurance and Monitoring Committee (IDSMC) recommended apprehension the balloon aboriginal afterwards 90 randomized patients with alive JIA-associated uveitis showed that HUMIRA accumulated with methotrexate controlled ocular deepening bigger and was associated with a decidedly lower amount of analysis abortion than placebo.[6]

The analysis of the business allotment appliance (MAA) is actuality conducted beneath the centralized licensing procedure. A business allotment accommodation is advancing by September. If approved, the allotment will be accurate in all 28 affiliate states of the European Union, as able-bodied as Iceland, Liechtenstein and Norway. HUMIRA was accustomed by the European Medicines Agency (EMA) for the analysis of non-infectious intermediate, afterwards and panuveitis in adults in June 2016.

HUMIRA (adalimumab) Plaque Psoriasis: Clinical Data - humira patient enrollment form
HUMIRA (adalimumab) Plaque Psoriasis: Clinical Data – humira patient enrollment form | humira patient enrollment form

About the SYCAMORE Trial[6] The SYCAMORE analytic balloon was sponsored by the University Hospitals Bristol NHS Foundation Trust and accommodating by the Analytic Trials Analysis Centre at the University of Liverpool. The abstraction was accurate by grants from the National Institute for Bloom Analysis Bloom Technology Assessment Programme and Arthritis Analysis UK. In this multicenter, double-masked, randomized, placebo-controlled trial, advisers adjourned the ability and assurance of HUMIRA in accouchement and adolescents two years of age or earlier who had alive JIA-associated uveitis. Patients who were demography a abiding dosage of methotrexate were about assigned in a 2:1 arrangement to accept either HUMIRA (at a dosage of 20 mg or 40 mg, according to anatomy weight) or placebo, administered subcutaneously every two weeks. Patients connected the balloon dieting until analysis abortion or until 18 months had elapsed. They were followed for up to two years afterwards randomization. The primary endpoint was the time to analysis failure, authentic according to assorted apparatus of intraocular deepening that was based on the Standardization of Uveitis Nomenclature (SUN) criteria.[6]

Study after-effects showed that the accession of HUMIRA to methotrexate decidedly delayed the time to analysis abortion as compared with placebo and the pre-specified endlessly belief were met afterwards the acceptance of 90 of 114 patients. Advisers empiric 16 analysis failures in 60 patients (27 percent) in the HUMIRA accumulation against 18 analysis failures in 30 patients (60 percent) in the placebo accumulation (hazard ratio, 0.25; 95 percent aplomb breach [CI], 0.12 to 0.49; P<0.0001 [the pre-specified endlessly boundary]). Adverse contest were appear added frequently in patients accepting HUMIRA than in those accepting placebo (10.07 contest per patient-year [95 percent CI, 9.26 to 10.89] vs. 6.51 contest per patient-year [95 percent CI, 5.26 to 7.77]), as were austere adverse contest (0.29 contest per patient-year [95 percent CI, 0.15 to 0.43] vs. 0.19 contest per patient-year [95 percent CI, 0.00 to 0.40]).

About HUMIRA in the European Union[7] 

HUMIRA EU Ameliorative Indications[7] HUMIRA is accustomed for use in adults with abstinent to astringent alive and accelerating rheumatoid arthritis, astringent alive ankylosing spondylitis (AS), astringent axial spondyloarthritis after radiographic affirmation of AS, abstinent to astringent abiding applique psoriasis, alive and accelerating psoriatic arthritis, moderately to acutely alive Crohn’s disease, moderately to acutely alive ulcerative colitis and non-infectious intermediate, afterwards and panuveitis in adults. HUMIRA is accustomed for use in adults and adolescents from 12 years of age with alive abstinent to astringent hidradenitis suppurativa, and in pediatric patients with alive enthesitis-related arthritis, astringent abiding applique psoriasis, moderately to acutely alive Crohn’s disease, and alive polyarticular adolescent idiopathic arthritis. See Summary of Artefact Characteristics (SmPC) for abounding indications.

Important EU Assurance Advice HUMIRA is contraindicated in patients with alive tuberculosis or added astringent infections such as sepsis, and adept infections and in patients with abstinent to astringent affection abortion (NYHA chic III/IV). It is additionally contraindicated in patients acute to the alive actuality or to any of the excipients. The use of HUMIRA increases the accident of developing austere infections which may, in attenuate cases, be life-threatening. Attenuate cases of lymphoma and leukemia accept been appear in patients advised with HUMIRA. On attenuate occasions, a astringent blazon of blight alleged hepatosplenic T-cell lymphoma has been empiric and about after-effects in death. A accident for the development of malignancies in patients advised with TNF-antagonists cannot be excluded. The best frequently appear adverse contest beyond all break included respiratory infections, bang armpit reactions, cephalalgia and musculoskeletal pain.

TREMFYA® (guselkumab) Patient Support | HCP - humira patient enrollment form
TREMFYA® (guselkumab) Patient Support | HCP – humira patient enrollment form | humira patient enrollment form

Globally, prescribing advice varies; accredit to the alone country artefact characterization for complete information.

(See SmPC for abounding assurance details)

About AbbVie AbbVie is a global, research-driven biopharmaceutical aggregation committed to developing avant-garde avant-garde therapies for some of the world’s best circuitous and analytical conditions. The company’s mission is to use its expertise, committed bodies and different access to addition to clearly beforehand treatments beyond four primary ameliorative areas: immunology, oncology, virology and neuroscience. In added than 75 countries, AbbVie advisers are alive every day to beforehand bloom solutions for bodies about the world. For added advice about AbbVie, amuse appointment us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Forward-Looking Statements  Some statements in this account absolution may be advanced statements for purposes of the Private Securities Activity Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and agnate expressions, amid others, about analyze advanced statements. AbbVie cautions that these advanced statements are accountable to risks and uncertainties that may account absolute after-effects to alter materially from those adumbrated in the advanced statements. Such risks and uncertainties include, but are not bound to, challenges to bookish property, antagonism from added products, difficulties inherent in the analysis and development process, adverse activity or government action, and changes to laws and regulations applicative to our industry.

Additional advice about the economic, competitive, governmental, abstruse and added factors that may affect AbbVie’s operations is set alternating in Item 1A, “Risk Factors,” in AbbVie’s 2016 Annual Address on Form 10-K, which has been filed with the Securities and Barter Commission. AbbVie undertakes no obligation to absolution about any revisions to advanced statements as a aftereffect of consecutive contest or developments, except as appropriate by law.

TREMFYA® (guselkumab) Patient Support | HCP - humira patient enrollment form
TREMFYA® (guselkumab) Patient Support | HCP – humira patient enrollment form | humira patient enrollment form

References:

[1] Palejwala, N.V., Yeh, S. & Angeles-Han, S.T. Accepted Perspectives on Ophtalmic Manifestations of Adolescence 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 adolescent 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 advance of ache in adolescence uveitis. Ophthalmology. 2009 Aug;116(8):1544-1551.

Dosing Information for HUMIRA (adalimumab) | HUMIRA PRO - humira patient enrollment form
Dosing Information for HUMIRA (adalimumab) | HUMIRA PRO – humira patient enrollment form | humira patient enrollment form

[5] Bhat, P.V., MD; Goldstein, D.A., MD. Pediatric Antecedent 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 additional Methotrexate for Uveitis in Adolescent Idiopathic Arthritis. N Engl J Med. 2017;376:1637-46.

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

SOURCE AbbVie

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