- CHMP positive opinion is based on results
from three Phase 3 studies: two for induction and one for
maintenance1,2
- Crohn's
disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal tract, causing persistent
diarrhea, abdominal pain and can require urgent medical
care3,4
- If approved,
risankizumab will be the first specific IL-23 inhibitor for the
treatment of Crohn's disease in the European Union
(EU)
- The European Commission decision
is expected in the fourth quarter of 2022. This anticipated
approval would mark the third indication for risankizumab in the
EU
NORTH
CHICAGO, Ill., Sept. 19,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CMHP) adopted a positive opinion
recommending the approval of risankizumab (SKYRIZI®, 600
mg intravenous [IV] induction and 360 mg subcutaneous [SC]
maintenance therapy) for the treatment of adults with moderately to
severely active Crohn's disease who have had inadequate response,
lost response or were intolerant to conventional or biologic
therapy.
"We continue to raise the bar in researching treatments for
immune-mediated gastroenterological conditions through more
stringent and innovative clinical trial design, such as the first
time a Phase 3 trial has reported co-primary endpoints, endoscopic
response and clinical remission," said Neil
Gallagher, M.D., Ph.D., vice president, development, chief
medical officer, AbbVie. "With the recent CHMP recommendation for
risankizumab in Crohn's disease, we're getting closer toward
helping patients find sufficient disease control for this
disruptive condition."
AbbVie's application for the approval of risankizumab in Crohn's
disease is supported by data from three Phase 3 clinical trials —
ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance
study).1,2 Across all three studies, significantly more
patients treated with risankizumab achieved the co-primary
endpoints of endoscopic response and clinical
remission.1,2,5-10 This includes statistically
significant improvements in these endpoints at week 12 compared to
placebo with 600 mg intravenous infusions for the ADVANCE and
MOTIVATE induction studies.1,8,9 Additionally, a
significantly greater proportion of patients treated with
risankizumab 360 mg subcutaneous injections achieved endoscopic
response and clinical remission at 52 weeks compared to placebo
(patients treated with placebo after risankizumab induction) in the
FORTIFY maintenance study.2,10 Safety results of
risankizumab in Crohn's disease were consistent with the known
safety profile of risankizumab, with no new safety risks
observed.1,2,8-13
"Living with Crohn's disease can pose many challenges and
significantly impact a patient's health-related quality of life,"
said Marc Ferrante, M.D., Ph.D.,
Department of Gastroenterology and Hepatology, University Hospitals
Leuven, Belgium. "Risankizumab
could be an encouraging option for adult patients that continue to
have moderately to severely active Crohn's disease and I look
forward to the European Commission's final decision."
Use of risankizumab in Crohn's disease is not approved in the
European Union, and its safety and efficacy remain under
evaluation.
Risankizumab (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 tract, causing persistent
diarrhea and abdominal pain.3,4 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.3,4 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.14,15
About the ADVANCE and MOTIVATE Inductions Studies, and the
FORTIFY Maintenance Study1,2,8-10
The three Phase
3 studies are multicenter, randomized, double-blind,
placebo-controlled studies to evaluate the efficacy and safety of
risankizumab 600 mg and 1200 mg as induction therapy, and
risankizumab 180 mg and 360 mg as maintenance therapy in subjects
with moderately to severely active Crohn's disease. Topline results
of the ADVANCE and MOTIVATE induction studies were announced in
January 2021 and topline results
of the FORTIFY maintenance study were announced in June 2021. More information can be found on
www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE:
NCT03104413, FORTIFY: NCT03105102).
About SKYRIZI® (risankizumab)
SKYRIZI is
an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23
by binding to its p19 subunit.11,16 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.11,16 The approved dose for SKYRIZI for moderate
to severe plaque psoriasis and active psoriatic arthritis in the
European Union is 150 mg (either as two 75 mg prefilled syringe
injections or one 150 mg prefilled pen or prefilled syringe)
administered by subcutaneous injections at week 0 and 4 and every
12 weeks thereafter.11 The use of risankizumab in
Crohn's disease is not approved in the European Union and its
safety remains under review with the global regulatory authorities.
Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis,
Crohn's disease and ulcerative colitis are
ongoing.12,13,17
EU Indications and Important Safety Information about
SKYRIZI® (risankizumab)11
SKYRIZI
is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are candidates for systemic therapy.
SKYRIZI, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active psoriatic arthritis in adults
who have had an inadequate response or who have been intolerant to
one or more disease-modifying antirheumatic drugs (DMARDs).
SKYRIZI is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients. SKYRIZI may
increase the risk of infection. In patients with a chronic
infection, a history of recurrent infection, or known risk factors
for infection, SKYRIZI should be used with caution. Treatment with
SKYRIZI should not be initiated in patients with any clinically
important active infection until the infection resolves or is
adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be
evaluated for tuberculosis (TB) infection. Patients receiving
SKYRIZI should be monitored for signs and symptoms of active TB.
Anti-TB therapy should be considered prior to initiating SKYRIZI in
patients with a history of latent or active TB in whom an adequate
course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all
appropriate immunizations should be considered according to current
immunization guidelines. If a patient has received live vaccination
(viral or bacterial), it is recommended to wait at least 4 weeks
prior to starting treatment with SKYRIZI. Patients treated with
SKYRIZI should not receive live vaccines during treatment and for
at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper
respiratory infections. Commonly (greater than or equal to 1/100 to
less than 1/10) reported adverse reactions included tinea
infections, headache, pruritus, fatigue and injection site
reactions.
This is not a complete summary of all safety
information.
See SKYRIZI full summary of product characteristics (SmPC)
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 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 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.
References:
- D'Haens G., et al. Risankizumab as Induction Therapy for
Crohn's Disease. Lancet.
- Ferrante M., et al. Risankizumab as Maintenance Therapy for
Crohn's Disease. Lancet.
- 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 on January 11, 2022.
- Crohn's disease. Symptoms and Causes. Mayo Clinic. 2022.
Available at:
https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
Accessed on January 11, 2022.
- AbbVie. Data on File: ABVRRTI71474.
- AbbVie. Data on File: ABBVRRI71526.
- AbbVie. Data on File: ABVRRTI72293.
- A Study of the Efficacy and Safety of Risankizumab in
Participants With Moderately to Severely Active Crohn's Disease.
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/record/NCT03105128.
Accessed on December 18, 2020.
- A Study to Assess the Efficacy and Safety of Risankizumab in
Participants With Moderately to Severely Active Crohn's Disease Who
Failed Prior Biologic Treatment. ClinicalTrials.gov. 2020.
Available
at: https://clinicaltrials.gov/ct2/show/record/NCT03104413.
Accessed on December 18, 2020.
- A Study of the Efficacy and Safety of Risankizumab in
Participants With Crohn's Disease. ClinicalTrials.gov. 2021.
Available
at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed May
21, 2021.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available at:
https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.
- 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. 2022. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on
January 13, 2022.
- 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. 2022. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on
January 13, 2022.
- Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev
Gastroenterol Hepatol. 2015 Dec; 12(12):720-7. Doi:
10.1038/nrgastro.2015.150.
- The Economic Costs of Crohn's Disease and Ulcerative Colitis.
Access Economics Pty Limited. 2007. Available at:
https://crohnsandcolitis.org.au/wp-content/uploads/2022/02/Deloitte-Access-Economics-Report.pdf.
Accessed on January 11, 2022.
- Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23:
a key cytokine in inflammatory diseases. Ann Med. 2011
Nov;43(7):503-11.
- Pipeline – Our Science | AbbVie. AbbVie. 2022. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
January 13, 2022.
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