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.
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