- Oral presentations highlight efficacy and safety
outcomes from the upadacitinib (RINVOQ®) clinical trial
program in adults with moderately to severely active Crohn's
disease, and investigational use of linaclotide
(LINZESS®) in treating functional constipation in
pediatric patients aged 6 to 17 years
- Twenty-nine abstracts showcase AbbVie's vast
portfolio and continued commitment to changing the way patients
living with gastrointestinal disorders manage their
condition
NORTH
CHICAGO, Ill., May 6, 2023
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present
29 abstracts during the 2023 Digestive Disease Week (DDW) Annual
Meeting, May 6-9, 2023, being held in
Chicago and virtually.
"Our abstracts showcase our comprehensive, well-researched
gastroenterology portfolio," said Celine
Goldberger, M.D., vice president, and head of U.S. medical
affairs, AbbVie. "This collective evidence underscores data across
a range of digestive and inflammatory bowel diseases and reinforces
our commitment to improving patient care."
The oral and poster presentations from AbbVie feature research
across the company's gastroenterology portfolio, including data on
Crohn's disease, ulcerative colitis, and functional constipation.
Notable data presentations will include:
- Two oral presentations and several posters evaluating
investigational upadacitinib in adults with moderately to severely
active Crohn's disease, including data on fistulas and fissures and
among patients who previously failed biologic or conventional
treatment.
- Several posters of risankizumab in adults with moderately to
severely active Crohn's disease, including results from three Phase
3 studies (ADVANCE, MOTIVATE, and FORTIFY) assessing risankizumab
as induction therapy for patients who did not previously achieve a
clinical response to therapy, as well as long-term efficacy and
safety data.
- An oral presentation and posters assessing investigational
linaclotide in pediatric patients (ages 6 to 17 years) with
functional constipation, including efficacy and safety data from a
Phase 3 trial and an interim analysis of long-term safety from an
open-label trial.
Select AbbVie abstracts at 2023 DDW are outlined below. The full
list of 2023 DDW Annual Meeting e-Posters is available here.
Abstract
Title
|
Presentation
Details
All times
CDT
|
Crohn's
Disease
|
Efficacy and Safety of
Upadacitinib for the Treatment of Fistulas and
Fissures in Patients with Crohn's Disease
|
Oral Presentation
#947
AGA IBD: Real World
Data and Clinical Trials to Guide Care (Research Forum)
May 9, 2023
8:30 – 8:45
AM
|
Upadacitinib Improves
Endoscopic Outcomes in Patients with Moderate
to Severely Active Crohn's Disease Irrespective of Previous Failure
to
Respond to Biologics or Conventional Therapies
|
Oral Presentation
#1031
AGA Controlled Clinical
Trials in IBD (Research Forum)
May 9, 2023
11:00 – 11:15
AM
|
Delayed Clinical
Responders in Patients with Crohn's Disease Receiving
Upadacitinib Therapy
|
Poster
#Tu1705
IBD: Controlled
Clinical Trials in Humans (Poster Session)
May 9, 2023
12:30 – 1:30
PM
|
Upadacitinib
Pharmacokinetic and Exposure-Response Relationships in
Subjects with Crohn's Disease - Analyses of Phase 3
Studies
|
Poster
#Tu1733
IBD: Controlled
Clinical Trials in Humans (Poster Session)
May 9, 2023
12:30 – 1:30
PM
|
Additional Risankizumab
Treatment Is Effective in Patients with
Moderately to Severely Active Crohn's Disease Who Did Not
Achieve
CDAI Clinical Response with the Initial 12 Week Induction
Treatment:
Results From the ADVANCE, MOTIVATE, and FORTIFY Studies
|
Poster
#Tu1710
IBD: Controlled
Clinical Trials in Humans (Poster Session)
May 9, 2023
12:30 – 1:30
PM
|
Long-Term Efficacy and
Safety of Risankizumab Treatment in Patients
with Moderately to Severely Active Crohn's Disease: 104-Week
Results
from the FORTIFY Study
|
Poster
#Tu1730
IBD: Controlled
Clinical Trials in Humans (Poster Session)
May 9, 2023
12:30 – 1:30
PM
|
Safety Profile of
Risankizumab in Crohn's Disease Patients by Age:
Post-hoc Analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY
Studies
|
Poster
#Tu1717
IBD: Controlled
Clinical Trials in Humans (Poster Session)
May 9, 2023
12:30 – 1:30
PM
|
Functional
Constipation
|
Efficacy and Safety of
Linaclotide in Treating Functional Constipation in
Pediatric Patients aged 6-17 years: a Phase 3 Pivotal
Randomized
Placebo-Controlled Trial
|
Oral Presentation:
#145
AGA Pediatric
Functional and Motility Disorders (Research Forum)
May 6, 2023
10:15 – 10:30
AM
|
Time to Response of
Linaclotide in Treating Functional Constipation in
Pediatric Patients aged 6-17 years: Data from a Phase 3
Randomized
Placebo-Controlled Trial
|
Poster
#Mo2008
AGA Pediatric
Functional and Motility Disorders (Poster Session)
May 8, 2023
12:30 – 1:30
PM
|
Efficacy of Linaclotide
in Treating Symptoms of Incomplete Evacuation
and Straining in Pediatric Patients with Functional
Constipation
|
Poster
#Mo2007
AGA Pediatric
Functional and Motility Disorders (Poster Session)
May 8, 2023
12:30 – 1:30
PM
|
Long-term Safety of
Linaclotide in Treating Functional Constipation in
Pediatric Patients aged 6-17 years: Interim Analysis of an Open
Label,
Phase 3, Extension Trial
|
Poster
#Mo2016
AGA Pediatric
Functional and Motility Disorders (Poster Session)
May 8, 2023
12:30 – 1:30
PM
|
Safety of Linaclotide
in Pediatric Patients with Functional Constipation: A
Pooled Analysis of Placebo-Controlled, Randomized Controlled
Trials
|
Poster
#Mo2015
AGA Pediatric
Functional and Motility Disorders (Poster Session)
May 8, 2023
12:30 – 1:30
PM
|
Exocrine Pancreatic
Insufficiency
|
Development,
Generalizability of a Clinical Screening Tool for Exocrine
Pancreatic Insufficiency (EPI) in Patients with Definite Chronic
Pancreatitis
|
Poster
#Mo1419
AGA Exocrine Pancreatic
Diseases and Diabetes (Poster Session)
May 8, 2023
12:30 – 1:30
PM
|
Disease
State
|
Patients with Crohn's
Disease and Ulcerative Colitis Cycle Through
Multiple Medications Prior To Starting Advanced Therapy: A
Retrospective Study
|
Poster
#Sa1814
May 6, 2023
12:30 – 1:30
PM
|
Food Security in
Hispanics with IBD: A Barrier to Dietary Management
|
Poster
#EP141
AGA Diet and IBD
(ePoster section)
May 6, 2023
9:30 AM – 4:00
PM
|
Incidence Rates of
Gastrointestinal Perforation Among Patients with
Inflammatory Bowel Disease: Real-world Evidence from a Large US
Nationwide Claims Database
|
Poster
#Su1769
IBD: Diagnostics in IBD
(Poster Section)
May 7, 2023
12:30 – 1:30
PM
|
SKYRIZI® (risankizumab-rzaa) is part of a
collaboration between Boehringer Ingelheim and AbbVie, with AbbVie
leading development and commercialization of SKYRIZI globally.
LINZESS® (linaclotide) is part of a
collaboration between AbbVie and Ironwood Pharmaceuticals to share
development and commercialization of LINZESS in the United States.
The use of upadacitinib in Crohn's disease is not
approved by the U.S. Food and Drug Administration
(FDA). Its safety and efficacy are under evaluation as part of
ongoing registrational studies.
RINVOQ® (upadacitinib) U.S. Uses and
Important Safety Information1
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis when
1 or more medicines called tumor necrosis factor (TNF) blockers
have been used and did not work well or could not be
tolerated.
- Adults with active psoriatic arthritis when 1 or more
medicines called TNF blockers have been used and did not work well
or could not be tolerated.
- Adults with moderately to severely active ulcerative
colitis when 1 or more medicines called TNF blockers have been
used and did not work well or could not be tolerated.
- Adults with active ankylosing spondylitis when 1 or more
medicines called TNF blockers have been used and did not work well
or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis
(nr-axSpA) with objective signs of inflammation when a TNF
blocker medicine has been used and did not work well or could not
be tolerated.
It is not known if RINVOQ is safe and effective in children with
juvenile idiopathic arthritis, psoriatic arthritis, ulcerative
colitis, ankylosing spondylitis, or non-radiographic axial
spondyloarthritis.
- Adults and children 12 years of age and older with moderate
to severe eczema (atopic dermatitis [AD]) that did not respond
to previous treatment and their eczema is not well controlled with
other pills or injections, including biologic medicines, or when
the use of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and
older weighing at least 88 pounds (40 kg) with atopic
dermatitis.
It is not known if RINVOQ is safe and effective in children
under 12 years of age with atopic dermatitis.
What is the most important information I should know about
RINVOQ?
RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower your ability to
fight infections. Serious infections have happened while taking
RINVOQ, including tuberculosis (TB) and infections caused by
bacteria, fungi, or viruses that can spread throughout the body.
Some people have died from these infections. Your healthcare
provider (HCP) should test you for TB before starting RINVOQ and
check you closely for signs and symptoms of TB during treatment
with RINVOQ. You should not start taking RINVOQ if you have any
kind of infection unless your HCP tells you it is okay. If you get
a serious infection, your HCP may stop your treatment until your
infection is controlled. You may be at higher risk of developing
shingles (herpes zoster).
- Increased risk of death in people 50 years and older who
have at least 1 heart disease (cardiovascular) risk
factor.
- Cancer and immune system problems. RINVOQ may increase
your risk of certain cancers. Lymphoma and other cancers, including
skin cancers, can happen. Current or past smokers are at higher
risk of certain cancers, including lymphoma and lung cancer. Follow
your HCP's advice about having your skin checked for skin cancer
during treatment with RINVOQ. Limit the amount of time you spend in
sunlight. Wear protective clothing when you are in the sun and use
sunscreen.
- Increased risk of major cardiovascular (CV) events, such as
heart attack, stroke, or death, in people 50 years and older who
have at least 1 heart disease (CV) risk factor, especially if you
are a current or past smoker.
- Blood clots: Blood clots in the veins of the legs or
lungs and arteries can happen with RINVOQ. This may be
life-threatening and cause death. Blood clots in the veins of the
legs and lungs have happened more often in people who are 50 years
and older and with at least 1 heart disease (CV) risk factor.
- Allergic reactions. Symptoms such as rash (hives),
trouble breathing, feeling faint or dizzy, or swelling of your
lips, tongue, or throat, that may mean you are having an allergic
reaction have been seen in people taking RINVOQ. Some of these
reactions were serious. If any of these symptoms occur during
treatment with RINVOQ, stop taking RINVOQ and get emergency medical
help right away.
- Tears in the stomach or intestines and changes in certain
laboratory tests. Your HCP should do blood tests before you
start taking RINVOQ and while you take it. Your HCP may stop your
RINVOQ treatment for a period of time if needed because of changes
in these blood test results.
Do not take RINVOQ if you are allergic to upadacitinib or any
of the ingredients in RINVOQ. See the Medication Guide or
Consumer Brief Summary for a complete list of ingredients.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
- Are being treated for an infection, have an infection that
won't go away or keeps coming back, or have symptoms of an
infection such as:
-
- Fever, sweating, or chills
- Shortness of breath
- Warm, red, or painful skin or sores on your body
- Muscle aches
- Feeling tired
- Blood in phlegm
- Diarrhea or stomach pain
- Cough
- Weight loss
- Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with
TB.
- Are a current or past smoker.
- Have had a heart attack, other heart problems, or stroke.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), blood clots in the veins of your legs or lungs,
diverticulitis (inflammation in parts of the large intestine), or
ulcers in your stomach or intestines.
- Have other medical conditions including liver problems, low red
or white blood cell counts, diabetes, chronic lung disease, HIV, or
a weak immune system.
- Live, have lived, or have traveled to parts of the country,
such as the Ohio and Mississippi
River valleys and the Southwest, that increase your risk of getting
certain kinds of fungal infections. If you are unsure if you've
been to these types of areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine.
People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on findings in
animal studies, RINVOQ may harm your unborn baby. Your HCP will
check whether or not you are pregnant before you start RINVOQ. You
should use effective birth control (contraception) to avoid
becoming pregnant during treatment with RINVOQ and for 4 weeks
after your last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. Do not breastfeed during treatment with RINVOQ
and for 6 days after your last dose.
Tell your HCP about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. RINVOQ and other
medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
If you are not sure if you are taking any of these medicines,
ask your HCP or pharmacist.
What should I avoid while taking RINVOQ?
Avoid food or drink containing grapefruit during treatment with
RINVOQ as it may increase the risk of side effects.
What should I do or tell my HCP AFTER starting
RINVOQ?
- Tell your HCP right away if you have any symptoms of an
infection. RINVOQ can make you more likely to get infections or
make any infections you have worse.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while taking RINVOQ, including:
-
- Discomfort in the center of your chest that lasts for more than
a few minutes or that goes away and comes back
- Severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- Pain or discomfort in your arms, back, neck, jaw, or
stomach
- Shortness of breath with or without chest discomfort
- Breaking out in a cold sweat
- Nausea or vomiting
- Feeling lightheaded
- Weakness in one part or on one side of your body
- Slurred speech
- Tell your HCP right away if you have any signs or symptoms of
blood clots during treatment with RINVOQ, including:
-
- Swelling
- Pain or tenderness in one or both legs
- Sudden unexplained chest or upper back pain
- Shortness of breath or difficulty breathing
- Tell your HCP right away if you have a fever or stomach-area
pain that does not go away, and a change in your bowel habits.
What are other possible side effects of
RINVOQ?
Common side effects include upper respiratory tract infections
(common cold, sinus infections), shingles (herpes zoster), herpes
simplex virus infections (including cold sores), bronchitis,
nausea, cough, fever, acne, headache, increased blood levels of
creatine phosphokinase, allergic reactions, inflammation of hair
follicles, stomach-area (abdominal) pain, increased weight, flu,
tiredness, lower number of certain types of white blood cells
(neutropenia, lymphopenia), muscle pain, flu-like illness, rash,
increased blood cholesterol levels, and increased liver enzyme
levels.
A separation or tear to the lining of the back part of the eye
(retinal detachment) has happened in people with atopic dermatitis
treated with RINVOQ. Call your HCP right away if you have any
sudden changes in your vision during treatment with RINVOQ.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split,
crush, or chew the tablet. Take RINVOQ exactly as your HCP tells
you to use it. RINVOQ is available in 15 mg, 30 mg and 45 mg
extended-release tablets.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit 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 the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
LINZESS® (linaclotide) Uses and Important Safety
Information2
USES
LINZESS® (linaclotide) is a prescription medication
used in adults to treat irritable bowel syndrome with constipation
(IBS-C) and chronic idiopathic constipation (CIC). "Idiopathic"
means the cause of the constipation is unknown. It is not known
if LINZESS is safe and effective in children less than 18 years of
age.
IMPORTANT RISK INFORMATION
- Do not give LINZESS to children who are less than 2 years of
age. It may harm them. LINZESS can cause severe diarrhea and
your child could get severe dehydration (loss of a large amount of
body water and salt).
- Do not take LINZESS if a doctor has told you that you have a
bowel blockage (intestinal obstruction).
Before you take LINZESS, tell your doctor about your medical
conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if LINZESS
will harm your unborn baby.
- Breastfeeding or plan to breastfeed. You and your doctor should
decide if you will take LINZESS and breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
Side Effects
LINZESS can cause serious side effects, including diarrhea,
which is the most common side effect and can sometimes be
severe. Diarrhea often begins within the first 2 weeks of
LINZESS treatment. Stop taking LINZESS and call your doctor
right away if you get severe diarrhea during treatment with
LINZESS.
Other common side effects of LINZESS include gas, stomach-area
(abdominal) pain, swelling, or a feeling of fullness or pressure in
your abdomen (distension). Call your doctor or go to the nearest
hospital emergency room right away if you develop unusual or severe
stomach-area (abdominal) pain, especially if you also have bright
red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more
information, ask your doctor or pharmacist.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
and Ironwood may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please see full Prescribing Information including Boxed
Warning.
SKYRIZI (risankizumab-rzaa) U.S. Uses and Important Safety
Information3
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).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn's disease.
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious
side effects, including:
Serious allergic reactions:
- Stop using SKYRIZI and get emergency help right away if you get
any of the following symptoms of serious allergic reaction:
-
- Fainting, dizziness, feeling lightheaded (low blood
pressure)
- Swelling of your face, eyelids, lips, mouth, tongue, or
throat
- Trouble breathing or throat tightness
- Chest tightness
- Skin rash, hives
- Itching
Infections:
SKYRIZI 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
- Cough
- Shortness of breath
- Blood in your mucus (phlegm)
- Muscle aches
- Warm, red, or painful skin or sores on your body different from
your psoriasis
- Weight loss
- Diarrhea or stomach pain
- Burning when you urinate or urinating more often than
normal
Do not use SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI. See the
Medication Guide or Consumer Brief Summary for a complete list of
ingredients.
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.
- Become pregnant while taking SKYRIZI. You are encouraged to
enroll in the Pregnancy Registry, which is used to collect
information about the health of you and your baby. Talk to your
healthcare provider or call 1-877-302-2161 to enroll in this
registry.
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?"
Liver problems in Crohn's disease: A person with Crohn's
disease who received SKYRIZI through a vein in the arm developed
changes in liver blood tests with a rash that led to
hospitalization. Your healthcare provider will do blood tests to
check your liver before, during, and up to 12 weeks of treatment
and may stop treatment with SKYRIZI if you develop liver problems.
Tell your healthcare provider right away if you notice any of the
following symptoms: unexplained rash, nausea, vomiting, stomach
(abdominal) pain, tiredness (fatigue), loss of appetite, yellowing
of the skin and eyes (jaundice), and dark urine.
The most common side effects of SKYRIZI in people treated for
Crohn's disease include: upper respiratory infections,
headache, joint pain, stomach (abdominal) pain, injection site
reactions, low red blood cells (anemia), fever, back pain, and
urinary tract infection.
The most common side effects of SKYRIZI in people treated for
plaque psoriasis and psoriatic arthritis include: upper
respiratory infections, headache, feeling tired, injection site
reactions, and fungal skin infections.
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, a
600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or
360 mg/2.4 mL single-dose prefilled cartridge with an on-body
injector.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit 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 Digestive Disease Week®
Digestive Disease Week®
(DDW) is the largest international gathering of physicians,
researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly
sponsored by the American Association for the Study of Liver
Diseases (AASLD), the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal
Endoscopy (ASGE) and the Society for Surgery of the Alimentary
Tract (SSAT), DDW is an in-person and online meeting from
May 6-9, 2023. The meeting showcases
more than 3,100 abstracts and hundreds of lectures on the latest
advances in GI research, medicine and technology. More information
can be found at www.ddw.org.
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 our 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 2022 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.
US-MULT-230315
References:
- RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- LINZESS (linaclotide) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- SKYRIZI (risankizumab) [Package Insert]. North
Chicago, Ill.: AbbVie Inc.
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SOURCE AbbVie