NORTH CHICAGO, Ill.,
Sept. 16, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that it has submitted applications
seeking approval for upadacitinib (15 mg and 30 mg (maintenance
dose) and 45 mg (induction dose)) for the treatment of adults with
moderately to severely active ulcerative colitis to the U.S. Food
and Drug Administration (FDA), and to the European Medicines Agency
(EMA) for the treatment of adults with moderately to severely
active ulcerative colitis, who have had an inadequate response,
lost response, or were intolerant to either conventional therapy or
a biologic agent.
"Many people continue to struggle with symptoms associated with
their ulcerative colitis, such as fatigue, bowel urgency, bloody
diarrhea and abdominal pain," said Tom
Hudson, senior vice president of research and development,
chief scientific officer, AbbVie. "Upadacitinib has the potential
to be an important new treatment option for people with ulcerative
colitis, who want to address these challenging and disruptive
symptoms. We look forward to working with regulatory authorities
and hope to bring upadacitinib to people with ulcerative colitis as
quickly as possible."
The applications are supported by data from two Phase 3
induction studies and one maintenance study.1-3 In these
studies, significantly more patients treated with
upadacitinib achieved the primary endpoint of clinical
remission (per Adapted Mayo Score) and all secondary endpoints
compared to placebo with 45 mg once daily at week 8 for the
induction studies, and with 15 mg and 30 mg once daily at 52 weeks
for the maintenance study.1-3
The safety results of upadacitinib, including the 45 mg dose as
induction therapy, in these studies were generally consistent with
the known safety profile of upadacitinib, with no new
important safety risks observed.1-7
About Ulcerative Colitis
Ulcerative colitis is a
chronic, idiopathic, immune-mediated inflammatory bowel disease
(IBD) of the large intestine that causes continuous mucosal
inflammation extending, to a variable extent, from the rectum to
the more proximal colon.15,16 The hallmark signs and
symptoms of ulcerative colitis include rectal bleeding, abdominal
pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and
fecal incontinence.15,17 The disease course of
ulcerative colitis varies between patients and can range from
quiescent disease to chronic refractory disease, which in some
cases can lead to surgery or complications, including cancer or
death.16,19 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.18
About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE
Maintenance Studies1-3,14-16
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 subjects with moderate to severe ulcerative colitis.
Topline results of the U-ACHIEVE induction study were announced in
December 2020, topline results of the
second induction study, U-ACCOMPLISH, were announced in
February 2021, and topline results of
the U-ACHIEVE maintenance study were announced in June 2021. More information can be found on
www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory
diseases.1-3,14-22 In human cellular assays, RINVOQ
preferentially inhibits signaling by JAK1 or JAK1/3 with functional
selectivity over cytokine receptors that signal via pairs of
JAK2.30 RINVOQ 15 mg is approved in the U.S. for adults
with moderately to severely active rheumatoid arthritis. RINVOQ 15
mg also is approved in the EU for adults with moderate to severe
active rheumatoid arthritis, adults with active psoriatic arthritis
(PsA), adults with active ankylosing spondylitis (AS), and adults
and adolescents 12 years and older with moderate to severe atopic
dermatitis (AD). RINVOQ 30 mg is approved in the EU for adults with
moderate to severe AD under age 65. Phase 3 trials of RINVOQ in
rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial
spondylarthritis, Crohn's disease, ulcerative colitis, giant cell
arteritis and Takayasu arteritis are ongoing.21-29 Use
of RINVOQ in ulcerative colitis is not approved and its safety and
efficacy have not been evaluated by regulatory authorities.
Important Safety Information about RINVOQ (upadacitinib) in
the United States
RINVOQ
U.S. Use and Important Safety Information
RINVOQ is a
prescription medicine used to treat adults with moderate to severe
rheumatoid arthritis in whom methotrexate did not work well or
could not be tolerated. It is not known if RINVOQ is safe and
effective in children under 18 years of age.
What is the most important information I should know about
RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune
system to fight infections. You should not start taking RINVOQ if
you have any kind of infection unless your healthcare provider
(HCP) tells you it is okay.
- Serious infections have happened in some people 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 HCP
should test you for TB before starting RINVOQ and check you closely
for signs and symptoms of TB during treatment with RINVOQ. You may
be at higher risk of developing shingles (herpes zoster).
- Lymphoma and other cancers, including skin cancers, can
happen in people taking RINVOQ.
- Blood clots in the veins of the legs or lungs and arteries
are possible in some people taking RINVOQ. This may be
life-threatening and cause death.
- Tears in the stomach or intestines and changes in certain
laboratory tests can happen. 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.
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.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), or 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 that
increase your risk of getting certain kinds of fungal infections,
such as the Ohio and Mississippi River valleys and the
Southwest. If you are unsure if you've been to these 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 while taking RINVOQ and for at least 4 weeks after your
last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. You should not breastfeed while taking RINVOQ and
for at least 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
Ask your HCP or pharmacist if you are not sure if you are taking
any of these medicines.
What should I 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.
- Have any signs or symptoms of blood clots during treatment with
RINVOQ, including:
-
- Swelling
- Sudden unexplained chest pain
- Pain or tenderness in the leg
- Shortness of breath
- Have a fever or stomach-area pain that does not go away, and a
change in your bowel habits.
What are the common side effects of RINVOQ?
These
include: upper respiratory tract infections (common cold, sinus
infections), nausea, cough, and fever. These are not all the
possible side effects of RINVOQ.
RINVOQ is taken once a day with or without food. Do not split,
break, crush, or chew the tablet. Take RINVOQ exactly as your HCP
tells you to use it.
Please see the Full Prescribing Information, including
the Medication Guide, for RINVOQ.
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.
Important EU Safety Information about
RINVOQ® (upadacitinib)30
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active
rheumatoid arthritis in adult patients who have responded
inadequately to, or who are intolerant to one or more
disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used
as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis
in adult patients who have responded inadequately to, or who are
intolerant to one or more DMARDs. RINVOQ may be used as monotherapy
or in combination with methotrexate.
Ankylosing spondylitis
RINVOQ is indicated for the treatment of active ankylosing
spondylitis in adult patients who have responded inadequately to
conventional therapy.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic
dermatitis in adults and adolescents 12 years and older who are
candidates for systemic therapy.
Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active
substance or to any of the excipients, in patients with active
tuberculosis (TB) or active serious infections, in patients with
severe hepatic impairment, and during pregnancy.
Special warnings and precautions for use
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not
recommended.
Serious infections
Serious and sometimes fatal infections have been reported in
patients receiving upadacitinib. The most frequent serious
infections reported included pneumonia and cellulitis. Cases of
bacterial meningitis have been reported. Among opportunistic
infections, TB, multidermatomal herpes zoster, oral/esophageal
candidiasis, and cryptococcosis have been reported with
upadacitinib. As there is a higher incidence of infections in
patients ≥65 years of age, caution should be used when treating
this population.
Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported
in clinical studies. The risk of herpes zoster appears to be higher
in Japanese patients treated with upadacitinib.
Vaccinations
The use of live, attenuated vaccines during or immediately prior to
therapy is not recommended. It is recommended that patients be
brought up to date with all immunizations, including prophylactic
zoster vaccinations, prior to initiating upadacitinib, in agreement
with current immunization guidelines.
Malignancy
The risk of malignancies, including lymphoma is increased in
patients with rheumatoid arthritis (RA). Malignancies, including
nonmelanoma skin cancer (NMSC), have been reported in patients
treated with upadacitinib. Consider the risks and benefits of
upadacitinib treatment prior to initiating therapy in patients with
a known malignancy other than a successfully treated NMSC or when
considering continuing upadacitinib therapy in patients who develop
a malignancy.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily
interrupted, in patients with hematological abnormalities observed
during routine patient management.
Cardiovascular risk
RA patients have an increased risk for cardiovascular disorders.
Patients treated with upadacitinib should have risk factors (e.g.,
hypertension, hyperlipidemia) managed as part of usual standard of
care.
Lipids
Upadacitinib treatment was associated with dose-dependent increases
in lipid parameters, including total cholesterol, low-density
lipoprotein cholesterol, and high-density lipoprotein
cholesterol.
Hepatic transaminase elevations
Treatment with upadacitinib was associated with an increased
incidence of liver enzyme elevation compared to placebo.
Venous thromboembolisms
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE)
have been reported in patients receiving JAK inhibitors, including
upadacitinib. Upadacitinib should be used with caution in patients
at high risk for DVT/PE.
Adverse reactions
The most commonly reported adverse reactions in rheumatoid
arthritis, psoriatic arthritis, and ankylosing spondylitis clinical
trials (≥2% of patients in at least one of the indications) with
upadacitinib 15 mg were upper respiratory tract infections, blood
creatine phosphokinase (CPK) increased, alanine transaminase
increased, bronchitis, nausea, cough, aspartate transaminase
increased, and hypercholesterolemia.
The most commonly reported adverse reactions in atopic
dermatitis trials (≥2% of patients) with upadacitinib 15 mg or 30
mg were upper respiratory tract infection, acne, herpes simplex,
headache, CPK increased, cough, folliculitis, abdominal pain,
nausea, neutropenia, pyrexia, and influenza.
Ankylosing spondylitis:
Overall, the safety profile observed in patients with active
ankylosing spondylitis treated with upadacitinib 15 mg was
consistent with the safety profile observed in patients with
RA.
Psoriatic arthritis:
Overall, the safety profile observed in patients with active
psoriatic arthritis treated with upadacitinib 15 mg was consistent
with the safety profile observed in patients with RA. A higher
incidence of acne and bronchitis was observed in patients treated
with upadacitinib 15 mg (1.3% and 3.9%, respectively) compared to
placebo (0.3% and 2.7%, respectively). A higher rate of serious
infections (2.6 events per 100 patient-years and 1.3 events per 100
patient-years, respectively) and hepatic transaminase elevations
(ALT elevations Grade 3 and higher rates 1.4% and 0.4%,
respectively) was observed in patients treated with upadacitinib in
combination with MTX therapy compared to patients treated with
monotherapy. There was a higher rate of serious infections in
patients ≥65 years of age, although data are limited.
Atopic dermatitis:
Dose-dependent changes in ALT increased and/or AST increased (≥ 3 x
ULN), lipid parameters, CPK values (> 5 x ULN), and
neutropenia (ANC < 1 x 109 cells/L)
associated with upadacitinib treatment were similar to what was
observed in the rheumatologic disease clinical studies. Based on
limited data in atopic dermatitis patients aged 65 years and older,
there was a higher rate of overall adverse reactions with the
upadacitinib 30 mg dose compared to the 15 mg dose. The safety
profile for upadacitinib 15 mg in adolescents was similar to that
in adults. The safety and efficacy of the 30 mg dose in adolescents
are still being investigated.
This is not a complete summary of all safety
information.
Please see the full SmPC for complete prescribing information
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.
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