NORTH CHICAGO, Ill.,
Sept. 20, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that it has submitted an application
to the U.S. Food and Drug Administration (FDA) seeking approval for
risankizumab-rzaa (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 Crohn's disease. The submission is supported by
safety and efficacy data from three Phase 3 studies – ADVANCE,
MOTIVATE and FORTIFY.
"While there have been advancements in care, many people with
Crohn's disease do not achieve lasting remission," said
Tom Hudson, senior vice president of
research and development, chief scientific officer, AbbVie. "This
submission is an important step forward in our commitment to
providing an additional treatment option for those who struggle
with this debilitating and often unpredictable disease."
In the analysis plans for the U.S. submission of the ADVANCE and
MOTIVATE induction studies, a significantly greater proportion of
patients with Crohn's disease treated with either dose of
risankizumab-rzaa IV induction therapy (600 mg or 1200 mg) met the
co-primary endpoints of clinical remission and endoscopic response
at week 12 compared to placebo.1,2
In the analysis plans for the U.S. submission of the FORTIFY
trial, a randomized-withdrawal maintenance trial of patients with
clinical response to risankizumab-rzaa induction therapy, a
significantly greater proportion of participants achieved the
co-primary endpoints of endoscopic response and clinical remission
with risankizumab-rzaa SC maintenance therapy at one year (52
weeks) for both assessed doses (360 mg or 180 mg), compared to
those who were randomized to the withdrawal arm and received
placebo SC (control group).3
The safety profile of all tested doses of risankizumab-rzaa in
moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and
FORTIFY studies was generally consistent with the known safety
profile of risankizumab-rzaa.1-7
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,
abdominal pain, and rectal bleeding.9-11 It is a
progressive disease, meaning it can get worse over
time.10,11 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.8
About the ADVANCE and MOTIVATE
Studies12-14
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-rzaa, 600 mg and 1200 mg, in adults with
moderate to severe Crohn's disease, compared to placebo. 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, and additional analyses were
presented at Digestive Disease Week® (DDW)
Virtual Conference 2021. More information can be found
on www.clinicaltrials.gov (ADVANCE: NCT03105128;
MOTIVATE: NCT03104413).
About the FORTIFY Study3,15
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-rzaa 180 mg and 360 mg as maintenance
therapy versus withdrawal who responded to risankizumab-rzaa
induction treatment in the ADVANCE and MOTIVATE studies. Topline
results were announced in June 2021.
An open label extension of FORTIFY will continue to assess the
long-term safety of risanzikumab-rzaa in subjects who completed
participation in FORTIFY. More information can be found on
www.clinicaltrials.gov (NCT03105102).
About Risankizumab-rzaa (SKYRIZI®)
SKYRIZI
is an interleukin-23 (IL-23) inhibitor that selectively blocks
IL-23 by binding to its p19 subunit.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.16,17 In April 2019, SKYRIZI
received U.S. Food and Drug Administration approval for the
treatment of moderate to severe plaque psoriasis in adults who are
candidates for systemic therapy or phototherapy. The approved dose
for SKYRIZI is 150 mg, administered by a prefilled pen or prefilled
syringe at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was
also approved by the European Commission in April 2019. Phase
3 trials of SKYRIZI in psoriatic arthritis, Crohn's disease, and
ulcerative colitis are ongoing.13-15, 18-21 The use
of risankizumab-rzaa in Crohn's disease is not approved and its
safety and efficacy have not been established by regulatory
authorities.
About Risankizumab-rzaa (SKYRIZI®)
in the United States16
SKYRIZI is a prescription medicine used to treat adults with
moderate to severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using
ultraviolet or UV light (phototherapy).
Important Safety Information
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI may cause serious side effects, including infections.
SKYRIZI is a prescription medicine that may lower the ability of
your immune system to fight infections and may increase your risk
of infections. Your healthcare provider should check you for
infections and tuberculosis (TB) before starting treatment with
SKYRIZI and may treat you for TB before you begin treatment with
SKYRIZI if you have a history of TB or have active TB. Your
healthcare provider should watch you closely for signs and symptoms
of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
-
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when you urinate or urinating more often than
normal
Before using SKYRIZI, tell your healthcare provider about all
of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). Medications that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI. Tell
your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most
important information I should know about SKYRIZI?"
The most common side effects of SKYRIZI include upper
respiratory infections, feeling tired, fungal skin infections,
headache, and injection site reactions.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it. SKYRIZI is available in a 150 mg/mL prefilled syringe and
pen.
This is not a complete summary of all safety
information.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for Full Prescribing
Information and Medication Guide for SKYRIZI.
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, Instagram, YouTube and LinkedIn.
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.
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- AbbVie. Data on File: ABBVRRI71526.
- AbbVie. Data on File: ABVRRTI722293.
- 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.
- Reich, K., et al. Risankizumab compared with adalimumab in
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10.1016/S0140-6736(19)30952-3.
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Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded
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- Feagan, B., et al. Induction therapy with the selective
interleukin-23 inhibitor risankizumab in patients with
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- The Economic Cost of Crohn's Disease and Ulcerative Colitis.
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- Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev
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Accessed on August 26, 2021.
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- A Study Comparing Risankizumab to Placebo in Participants With
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