NORTH CHICAGO, Ill.,
Nov. 30, 2021 /PRNewswire/ -- AbbVie
(NYSE:ABBV) today announced it has submitted an application to
the European Medicines Agency (EMA) seeking approval for
risankizumab (SKYRIZI®, 600 mg intravenous (IV)
induction and 360 mg subcutaneous (SC) maintenance therapy), an
interleukin-23 (IL-23) inhibitor, for the treatment of patients 16
years and older with moderate to severe active Crohn's disease who
have had inadequate response, lost response or were intolerant to
conventional or biologic therapy. The submission is supported by
three pivotal Phase 3 studies, ADVANCE, MOTIVATE and
FORTIFY.1,2
"Patients with moderate to severe Crohn's disease live with
challenging symptoms, such as persistent diarrhea and abdominal
pain, impacting their quality of life," said Tom
Hudson, senior vice president of research and development,
chief scientific officer, AbbVie. "We look forward to working with
the regulatory authorities and hope to offer risankizumab as a
potential first-in-class treatment option for patients living with
this disease."
In the Phase 3 ADVANCE and MOTIVATE induction studies, a
significantly greater proportion of patients with Crohn's disease
treated with risankizumab IV induction therapy 600 mg achieved both
primary endpoints demonstrating statistically significant results
for clinical remission and endoscopic response at week 12 compared
to placebo.1
In the Phase 3 FORTIFY maintenance study evaluating Crohn's
disease patients with clinical response to risankizumab IV
induction treatment, a significantly greater proportion of patients
treated with risankizumab 360 mg SC achieved endoscopic response
and clinical remission at one year (52 weeks) versus those who were
withdrawn from risankizumab (control group).2
No new safety risks were observed in moderate to severe Crohn's
disease in the ADVANCE, MOTIVATE and FORTIFY studies compared to
the known safety profile of risankizumab.1-6
The use of risankizumab for Crohn's disease is not approved and
its safety and efficacy have not been established by regulatory
authorities.
Risankizumab (SKYRIZI) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal (or digestive) tract,
causing persistent diarrhea and abdominal pain.8-10 It
is a progressive disease, meaning it gets worse over time, and in
many cases leads to surgery.9,10 Because the signs
and symptoms of Crohn's disease are unpredictable, it causes a
significant burden on people living with the disease—not only
physically, but also emotionally and economically.12
About the ADVANCE and MOTIVATE
Studies1,13,14
The ADVANCE and MOTIVATE studies are Phase 3, multicenter,
randomized, double-blind, placebo-controlled induction studies
designed to evaluate the efficacy and safety of two doses of
risankizumab, 600 mg and 1200 mg, in adults with moderate to severe
Crohn's disease, compared to placebo. Both studies included
different sets of primary and secondary endpoints for outside U.S.
(OUS) protocol and U.S. protocol. The primary endpoints were
achievement of clinical remission (per PRO-2 for the OUS protocol,
which was measured by daily stool frequency and abdominal pain
score, and per CDAI for the U.S. protocol, which was measured by a
CDAI score less than 150) and endoscopic response (for both
protocols) at week 12. Endoscopic response is defined as a decrease
in SES-CD of greater than 50 percent from baseline (or at least a
greater than or equal to 50 percent decrease from baseline in
patients with isolated ileal disease and a baseline SES-CD of 4),
as scored by a central reviewer.
The ADVANCE study included a mixed population of patients who
had responded inadequately or are intolerant to conventional and/or
biologic therapy. The MOTIVATE study evaluated patients who had
responded inadequately or were intolerant to biologic therapy.
Topline results of the studies were shared in January 2021. More information can be found
on www.clinicaltrials.gov (ADVANCE: NCT03105128;
MOTIVATE: NCT03104413).
About the FORTIFY Study2,15
The FORTIFY study is a Phase 3, multicenter, randomized,
double-blind, control group, 52-week maintenance study designed to
evaluate the efficacy and safety of risankizumab 180 mg and 360 mg
as maintenance therapy versus withdrawal in patients who responded
to risankizumab induction treatment in the ADVANCE and MOTIVATE
studies. This study included different sets of primary and
secondary endpoints for the OUS analysis plan and U.S. analysis
plan due to regulatory requirements in the different regions. The
co-primary endpoints were achievement of endoscopic response and
clinical remission at week 52. Endoscopic response is defined as a
decrease in SES-CD of greater than 50 percent from baseline (or at
least a greater than or equal to 50 percent decrease from baseline
in patients with isolated ileal disease and a baseline SES-CD of
4), as scored by a central reviewer. Clinical remission is defined
by SF/AP, which was measured by daily stool frequency and abdominal
pain score, in the OUS analysis plan and defined by CDAI, which was
measured by a CDAI score less than 150, in the U.S. analysis
plan.
Topline results were announced in June 2021. An open label extension of FORTIFY
will continue to assess the long-term safety of risankizumab in
subjects who completed participation in FORTIFY. More information
can be found on www.clinicaltrials.gov (NCT03105102).
About
SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.7,16 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases, including
Crohn's disease.16 The approved dose for SKYRIZI for
moderate to severe plaque psoriasis and active psoriatic arthritis
in the European Union is 150 mg (either as two 75 mg pre-filled
syringe injections or one 150 mg prefilled pen or pre-filled
injections) administered by subcutaneous injections at week 0 and 4
and every 12 weeks thereafter. The use of risankizumab in
Crohn's disease is not approved and its safety and efficacy have
not been established by regulatory authorities. Phase 3 trials of
SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and
psoriatic arthritis are ongoing.15,17-19
Important EU Indication and Safety Information
about SKYRIZI® (risankizumab)7
SKYRIZI is indicated for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy.
SKYRIZI, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active psoriatic arthritis in adults
who have had an inadequate response or who have been intolerant to
one or more disease-modifying antirheumatic drugs (DMARDs).
SKYRIZI is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients. SKYRIZI may
increase the risk of infection. In patients with a chronic
infection, a history of recurrent infection, or known risk factors
for infection, SKYRIZI should be used with caution. Treatment with
SKYRIZI should not be initiated in patients with any clinically
important active infection until the infection resolves or is
adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be
evaluated for tuberculosis (TB) infection. Patients receiving
SKYRIZI should be monitored for signs and symptoms of active TB.
Anti-TB therapy should be considered prior to initiating SKYRIZI in
patients with a history of latent or active TB in whom an adequate
course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all
appropriate immunizations should be considered according to current
immunization guidelines. If a patient has received live vaccination
(viral or bacterial), it is recommended to wait at least 4 weeks
prior to starting treatment with SKYRIZI. Patients treated with
SKYRIZI should not receive live vaccines during treatment and for
at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper
respiratory infections. Commonly (greater than or equal to 1/100 to
less than 1/10) reported adverse reactions included tinea
infections, headache, pruritus, fatigue and injection site
reactions.
This is not a complete summary of all safety information. See
SKYRIZI full summary of product characteristics (SmPC)
at www.ema.europa.eu.
Globally, prescribing information varies; refer to the
individual country product label for complete
information.
About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to
cutting-edge research to drive exciting developments in
inflammatory bowel diseases (IBD), like ulcerative colitis and
Crohn's disease. By innovating, learning and adapting, AbbVie
aspires to eliminate the burden of IBD and make a positive
long-term impact on the lives of people with IBD. For more
information on AbbVie in gastroenterology, visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie
on Twitter, Facebook, LinkedIn or Instagram.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, 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,
failure to realize the expected benefits from AbbVie's acquisition
of Allergan plc ("Allergan"), failure to promptly and effectively
integrate Allergan's businesses, competition from other products,
challenges to intellectual property, difficulties inherent in the
research and development process, adverse litigation or government
action, changes to laws and regulations applicable to our industry
and the impact of public health outbreaks, epidemics or pandemics,
such as COVID-19. 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 2020 Annual Report on Form 10-K, which has been filed
with the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. 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:
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induction therapy in patients with moderate-to-severe Crohn's
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May 21–23.
- Ferrante, M. Efficacy and safety of risankizumab as maintenance
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Phase 3 FORTIFY study. United European Gastroenterology Week
Virtual 2021. LB13.
- Gordon K., et al. Efficacy and safety of risankizumab in
moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2):
results from two double-blind, randomised, placebo-controlled and
ustekinumab-controlled phase 3 trials. Lancet. 2018 Aug
25;392(10148):650-661.
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Results from the Phase 3 IMMhance Trial. Poster #478. 24th World
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- Feagan, B., et al. Induction therapy with the selective
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placebo-controlled phase 2 study. Lancet. 2017 Apr
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- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available at:
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Accessed on November 5, 2021.
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https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Accessed on November 5, 2021.
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Accessed on November 5, 2021.
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Accessed on November 5, 2021.
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- A Study Comparing Risankizumab to Placebo in Participants With
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