- Submissions are supported by three Phase 3 clinical trials
demonstrating upadacitinib achieved the co-primary endpoints of
clinical remission and endoscopic response as induction and
maintenance treatment1-4
- Safety results were generally consistent with the known
safety profile of upadacitinib, with no new safety risks
observed1-8
- Crohn's disease is a chronic, systemic disease that
manifests as inflammation within the gastrointestinal tract,
causing persistent diarrhea and abdominal
pain9,10
NORTH
CHICAGO, Ill., July 27,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that it has submitted applications for a new indication
to the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) for upadacitinib (RINVOQ®, 45 mg
[induction dose] and 15 mg and 30 mg [maintenance dose]) for the
treatment of adult patients with moderately to severely active
Crohn's disease.4,11
"Crohn's disease can be debilitating and have a significant
impact on a person's daily life," said Neil
Gallagher, M.D., Ph.D., vice president, development, chief
medical officer, AbbVie. "Those patients who are still suffering
fuel our continued commitment to innovation in care for patients
with IBD, and we look forward to potentially introducing a new
treatment option for this disruptive condition."
The applications to the FDA and EMA are supported by data from
three Phase 3 clinical trials, including two induction studies
(U-EXCEED & U-EXCEL) and one maintenance study
(U-ENDURE).1-4 Across all three studies, significantly
more patients treated with upadacitinib achieved the co-primary
endpoints of clinical remission and endoscopic response, with
clinical remission measured by the Crohn's Disease Activity Index
(CDAI) or by the patient-reported symptoms of stool
frequency/abdominal pain (SF/AP).1-4 Additionally, more
patients receiving upadacitinib 45 mg once daily at week 12 in the
induction studies or 15 mg and 30 mg once daily at 52 weeks in the
maintenance study achieved the secondary endpoint of
corticosteroid-free clinical remission per CDAI and per SF/AP
compared to placebo among patients taking corticosteroids at
baseline.1-4
The safety results of upadacitinib in U-EXCEED, U-EXCEL and
U-ENDURE were generally consistent with the known safety profile of
upadacitinib, with no new safety risks observed.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal tract, causing persistent
diarrhea and abdominal pain.9,10 It is a progressive
disease, meaning it gets worse over time in a substantial
proportion of patients or may develop complications that require
urgent medical care, including 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.10
About the U-EXCEED and U-EXCEL Induction and U-ENDURE
Maintenance Studies1,2,3
The three Phase 3
studies are multicenter, randomized, double-blind,
placebo-controlled studies to evaluate the efficacy and safety
of upadacitinib 45 mg once daily as induction therapy,
and upadacitinib 15 mg and 30 mg once daily as maintenance
therapy in adults with moderately to severely active Crohn's
disease. Topline results from U-EXCEED and U-EXCEL induction
studies were announced in December
2021 and February 2022,
respectively, and topline results from the U-ENDURE
maintenance study were announced in May
2022. These studies include assessments of efficacy, safety
and tolerability of upadacitinib. More information on these trials
can be found at www.clinicaltrials.gov (NCT03345836,
NCT03345849, NCT03345823).
About upadacitinib (RINVOQ®)
Discovered and
developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is
being studied in several immune-mediated inflammatory
diseases.1–8 Based on enzymatic and cellular
assays, RINVOQ demonstrated greater inhibitory potency for JAK-1
vs. JAK-2, JAK-3 and TYK-2. The relevance of
inhibition of specific JAK enzymes to therapeutic effectiveness and
safety is not currently known.12
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic
dermatitis, psoriatic arthritis, axial spondyloarthritis,
ulcerative colitis, giant cell arteritis and Takayasu arteritis are
ongoing.4–8,11,13-18 The use of
upadacitinib in Crohn's disease is not approved and its safety and
efficacy have not been evaluated by regulatory authorities.
RINVOQ® (upadacitinib) U.S. Use and
Important Safety Information12
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 moderate to severe 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.
It is not known if RINVOQ is safe and effective in children with
juvenile idiopathic arthritis, psoriatic arthritis, ulcerative
colitis, or ankylosing spondylitis.
- Adults and children 12 years of age and older with moderate
to severe eczema (atopic dermatitis) that did not respond to
previous treatment and their eczema is not well controlled with
other pills or injections, including biologic medicines, or 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.
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:
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- 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 or 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
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 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 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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
Please click here for the Full Prescribing Information and
Medication Guide.
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 2021 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.
U.S.
Media:
Sara Sanders
+1 (973)
307-6145
sara.sanders@abbvie.com
|
Global
Media: Jenina Nuñez
+ 1
(708) 603-5755
jenina.nunez@abbvie.com
|
Investors:
Liz
Shea +1 (847)
935-2211
liz.shea@abbvie.com
|
|
|
|
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