- Approval supported by two Phase 3 clinical trials that
evaluated SKYRIZI® for the treatment of moderate to
severe ulcerative colitis: a 12-week induction study,
INSPIRE,1 and a 52-week maintenance study,
COMMAND2
- Data showed that clinical remission, the primary endpoint in
both the induction and maintenance studies, was achieved along
with endoscopic improvement, a key secondary
endpoint1,2
- SKYRIZI is the first IL-23 antagonist approved for both
ulcerative colitis and Crohn's disease
NORTH
CHICAGO, Ill., June 18,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced the U.S. Food and Drug Administration (FDA) has approved
SKYRIZI® (risankizumab-rzaa) for adults with moderately
to severely active ulcerative colitis, making it the first IL-23
specific inhibitor approved for both moderate to severe ulcerative
colitis and moderate to severe Crohn's
disease.3 SKYRIZI is now approved for four
indications across immune-mediated inflammatory diseases.
Access the multimedia news release here:
https://www.multivu.com/players/English/9251951-abbvie-fda-ulcerative-colitis/
"When treating patients with ulcerative colitis, it's important
to prioritize both early and sustained clinical remission as well
as endoscopic improvement," said Edward V.
Loftus, Jr., M.D., Maxine and Jack Zarrow Family Professor
of Gastroenterology in the division of gastroenterology and
hepatology at Mayo Clinic in Rochester,
Minnesota. "This approval for SKYRIZI is an important
step toward addressing these treatment goals."
With over 1 million people living with ulcerative colitis,
the United States has one of the
largest populations affected by this disease and the numbers are
continuing to rise.4 Ulcerative colitis is a form of
inflammatory bowel disease (IBD) that causes inflammation in the
digestive tract and can result in damage to the colon
lining.5 Patients often experience a range of
unpredictable symptoms that impact their daily lives, such as
abdominal pain, bloody stool and urgency to use the
bathroom.5,6 The disease course of ulcerative
colitis varies between patients, and in some cases can lead to
surgery or complications, including cancer or
death.6,7
"Today's approval of SKYRIZI for ulcerative colitis expands our
IBD portfolio and demonstrates our commitment to helping address
ongoing needs of patients," said Roopal
Thakkar, M.D., senior vice president, chief medical officer,
global therapeutics, AbbVie. "We will continue to invest in
transforming the treatment landscape and the lives of people
suffering from lBD."
Dosing of SKYRIZI for this indication includes a 12-week
induction period with three 1200 mg doses delivered every four
weeks, followed by maintenance therapy of either 180 mg or 360 mg
delivered every eight weeks.3 Following the induction
period, SKYRIZI treatment can be maintained at home using an
on-body injector (OBI).3 The OBI is a hands-free device
designed with patients in mind that adheres to the body and takes
about five minutes to deliver the medication following preparation
steps.3
Do not use if you are allergic to SKYRIZI. SKYRIZI may cause
serious side effects, including serious allergic reactions, an
increased risk of infections, and liver problems. Stop using
SKYRIZI and get emergency medical help right away if experiencing
symptoms of a serious allergic reaction. Before starting treatment,
your doctor should check for infections and tuberculosis. Tell your
doctor right away about any infections or symptoms of infection and
about planned or recent vaccines. Liver problems may happen while
being treated for Crohn's disease or ulcerative colitis that can
lead to hospitalization. Your doctor will do liver blood tests
before and during treatment and may stop SKYRIZI if liver problems
develop.
Risankizumab (SKYRIZI) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
For more information about SKYRIZI, visit SKYRIZI.com.
Patient Access & Support
AbbVie is committed to helping people access SKYRIZI and other
medicines, including offering a patient support program and co-pay
card that may reduce out-of-pocket costs to as little as
$0 per month for eligible,
commercially insured patients. Financial support might also include
reimbursement for out-of-pocket costs related to IV administration.
For those with limited or no health insurance, AbbVie offers
myAbbVie Assist, a patient assistance program that provides SKYRIZI
at no charge to those who qualify. More information about this
assistance program can be found at
www.AbbVie.com/myAbbVieAssist.
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.5,8 The hallmark
signs and symptoms of ulcerative colitis include rectal bleeding,
abdominal pain, bloody diarrhea, tenesmus (a sense of pressure),
urgency and fecal incontinence.5,6
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.6,7 The severity
of symptoms and unpredictability of disease course can lead to
substantial burden and often disability among those living with the
disease.9
About the INSPIRE Induction Study1
INSPIRE is a multicenter, randomized, double-blind,
placebo-controlled Phase 3 study evaluating the efficacy and safety
of risankizumab 1200 mg IV administered every four weeks as
induction therapy in subjects with moderately to severely active
ulcerative colitis.
The primary endpoint is clinical remission (per Adapted Mayo
Score, defined as SFS ≤1 and not greater than baseline, RBS of
0 and endoscopic subscore ≤1 without friability) at week 12.
Secondary endpoints include clinical response (decrease from
baseline in the Adapted Mayo Score ≥2 points and ≥30% from
baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1),
endoscopic improvement (endoscopic subscore ≤1 without friability),
and histologic and endoscopic mucosal improvement (HEMI)
(endoscopic subscore of 0 or 1 without friability and Geboes score
≤3.1) at week 12. More information can be found on
www.clinicaltrials.gov (NCT03398148).
About the COMMAND Maintenance
Study2
The COMMAND study is a Phase 3, multicenter, randomized,
double-blind, controlled, 52-week maintenance study designed to
evaluate the efficacy and safety of risankizumab 180 mg or 360 mg
SC in adults with moderately to severely active ulcerative colitis.
This study followed a re-randomized withdrawal design in which all
patients received risankizumab IV induction and those who responded
to risankizumab were re-randomized to receive risankizumab 180 mg
or 360 mg SC or withdrawal from risankizumab treatment
(induction-only control group). For those randomized to withdraw
from risankizumab treatment (induction-only control group), the
rest of the study duration was a risankizumab washout. The
objective of the Phase 3 study is to evaluate the efficacy and
safety of risankizumab 180 mg or 360 mg as maintenance therapy
versus withdrawal from risankizumab treatment (control) in patients
with moderately to severely active ulcerative colitis who responded
to risankizumab IV induction in the INSPIRE study.
The primary endpoint is clinical remission (per Adapted Mayo
Score, defined as SFS ≤1 and not greater than baseline, RBS of
0 and endoscopic subscore ≤1 without evidence of friability) at
week 52. Secondary endpoints include endoscopic improvement
(endoscopic subscore ≤1 without evidence of friability), histologic
and endoscopic mucosal improvement (HEMI) (endoscopic subscore of
≤1 without evidence of friability and Geboes score ≤3.1), and
steroid-free clinical remission (defined as clinical remission per
Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days
prior to week 52) at week 52. More information can be found on
www.clinicaltrials.gov (NCT03398135).
About SKYRIZI®
(risankizumab-rzaa)
SKYRIZI is an
interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by
binding to its p19 subunit.10 IL-23, a cytokine involved
in inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases.11 SKYRIZI is approved
by the U.S. Food and Drug Administration (FDA) for the treatment of
moderately to severely active ulcerative colitis, plaque psoriasis,
psoriatic arthritis and Crohn's
disease.11,12,13
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.
- moderate to severe Crohn's disease.
- moderate to severe ulcerative colitis.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medicine that may cause serious
side effects, including:
Serious allergic reactions:
- Stop using SKYRIZI and get emergency medical help right
away if you get any of the following symptoms of a 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). Medicines 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 may happen while being treated
for Crohn's disease or ulcerative colitis: 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 at least 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 and ulcerative colitis include:
upper respiratory infections, headache, joint pain, stomach
(abdominal) pain, injection site reactions, low red blood cells
(anemia), fever, back pain, urinary tract infection, and
rash.
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 (risankizumab-rzaa) 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 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 the Full Prescribing Information and
Medication Guide.
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 – and products
and services in our Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and
YouTube.
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 and uses of future or conditional verbs,
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 expressed or implied in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. 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 2023 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, and specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
US-SKZG-240225
1 AbbVie. Data on file: ABVRRTI75696.
2 AbbVie. Data on File: ABVRRTI76012.
3 SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2024.
4 Lewis JD, Parlett LE, Jonsson Funk ML, et al.
Incidence, prevalence, and racial and ethnic distribution of
inflammatory bowel disease in the United
States. Gastroenterology. 2023;165(5).
doi:10.1053/j.gastro.2023.07.003
5 The Facts about Inflammatory Bowel Diseases. Crohn's
& Colitis Foundation of America. 2014. Available
at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Accessed June 2024.
6 Ulcerative colitis. Mayo Clinic. 2022. Available at:
https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326.
Accessed June 2024.
7 Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical
course and prognosis in ulcerative colitis: results from
population-based and observational studies. Ann
Gastroenterol. 2014;27(2):95-104.
8 Gajendran M, Loganathan P, Jimenez G, et al. A
comprehensive review and update on ulcerative colitis. Dis
Mon. 2019;65(12):100851.
doi:10.1016/j.disamonth.2019.02.004
9 Mehta F. Report: economic implications of inflammatory
bowel disease and its management. Am J Manag Care. 2016;22(3
Suppl):s51-60.
10 Duvallet E, Sererano L, Assier E, Falgarone G,
Boissier MC. Interleukin-23: a key cytokine in inflammatory
diseases. Ann Med. 2011;43(7):503-11.
doi:10.3109/07853890.2011.577093
11 Pipeline. AbbVie. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed
June 2024.
12 A study comparing risankizumab to placebo in
participants with active psoriatic arthritis including those who
have a history of inadequate response or intolerance to biologic
therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated June 18, 2024. Available
at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed
June 2024.
13 A multicenter, randomized, double-blind, placebo
controlled induction study to evaluate the efficacy and safety of
risankizumab in participants with moderately to severely active
ulcerative colitis. ClinicalTrials.gov. Updated August 1, 2023. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed
June 2024.
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SOURCE AbbVie