• CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance 1, 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 care a few, 4
  • If approved, risankizumab will be the first specific IL-23 inhibitor for the particular 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 within the EU

NORTH CHICAGO, Ill., Sept. 19, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced the European Medicines Agency’s (EMA) Committee with regard to Medicinal Products for Human Use (CMHP) adopted a positive opinion recommending the approval of risankizumab (SKYRIZI ® , 600 mg intravenous [IV] induction plus 360 magnesium subcutaneous [SC] maintenance therapy) for the particular remedying of adults with moderately to severely active Crohn’s disease who have had inadequate response, lost reaction or were intolerant in order to conventional or biologic therapy.

“We continue to raise the bar within 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 plus 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 illness control for this disruptive condition. ”

AbbVie’s application for that approval associated with risankizumab in Crohn’s disease is supported by data from 3 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 particular co-primary endpoints of endoscopic response plus clinical remission. one, 2, 5-10 This includes statistically significant improvements within these endpoints at week 12 compared to placebo along 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 medical remission at 52 weeks in comparison to placebo (patients handled with placebo after risankizumab induction) in the FORTIFY servicing 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 plus significantly impact a patient’s health-related quality of life, ” said Marc Ferrante, M. Deb., Ph. Deb., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. “Risankizumab could be an encouraging option regarding adult patients that continue to have moderately to severely active Crohn’s condition and I look forward to the particular European Commission’s final decision. ”

Use of risankizumab in Crohn’s disease is not authorized in the Eu, plus its security and efficacy remain under evaluation.

Risankizumab (SKYRIZI) will be part associated with a collaboration between Boehringer Ingelheim and AbbVie, along with AbbVie leading development plus commercialization globally.

About Crohn’s Disease
Crohn’s disease is a persistent, systemic disease that manifests as swelling within the particular gastrointestinal system, causing prolonged diarrhea and abdominal pain. three or more, 4 It is the progressive illness, meaning it gets worse over time in a substantial proportion of patients or even may develop complications that require urgent health care, including surgery. three or more, 4 Because the signs plus symptoms associated with 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

Regarding the ADVANCE and MOTIVATE Inductions Studies, and the FORTIFY Maintenance Study 1, two, 8-10
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled research to evaluate the particular efficacy and safety of risankizumab 600 mg plus 1200 magnesium as induction therapy, and risankizumab 180 mg plus 360 mg as upkeep therapy inside subjects along with moderately in order to severely energetic Crohn’s condition. Topline outcomes of the ADVANCE and MOTIVATE induction studies had been announced in January 2021 and topline results associated with 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 usually thought to be linked to a number of chronic immune-mediated diseases, including Crohn’s disease. eleven, 16 The particular approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the particular European Union is 150 mg (either as 2 75 magnesium prefilled syringe injections or one a hundred and fifty mg prefilled pen or even prefilled syringe) administered by subcutaneous injections at 7 days 0 plus 4 and every 12 several weeks thereafter. 11 The use of risankizumab within Crohn’s illness is not approved inside the European Union and the safety remains under review with the global regulatory authorities. Phase a few trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis are ongoing. 12, 13, 17

EU Indications plus Important Safety Information about SKYRIZI ® (risankizumab) 11
SKYRIZI is indicated for your treatment of moderate to serious plaque psoriasis in grown ups who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate (MTX), is definitely indicated intended for the treatment of active psoriatic arthritis in adults who have got had an inadequate response or even who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

SKYRIZI is contraindicated in individuals with hypersensitivity to the active substance or to any of the particular excipients. SKYRIZI may increase the risk of infection. In sufferers with a chronic contamination, a history associated with recurrent illness, or recognized risk factors for disease, SKYRIZI should be used with caution. Treatment with SKYRIZI should not really be initiated in individuals with any kind of clinically important active infections until the infection resolves or is adequately dealt with.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) an infection. Patients receiving SKYRIZI ought to be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in individuals with a history of latent or energetic TB in whom an adequate course of treatment cannot be confirmed.

Just before initiating treatment with SKYRIZI, completion associated with all appropriate immunizations need to be considered according to current immunization guidelines. If a patient has received live vaccination (viral or even bacterial), it is recommended to wait in least 4 weeks prior in order to starting therapy with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 days after treatment.

The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less compared to 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not the complete summary of all safety information.

See SKYRIZI full overview of product characteristics (SmPC) at www.ema.europa.eu .

Globally, prescribing info varies; refer to the individual country item label to get complete details.

Regarding AbbVie inside Gastroenterology
With a robust scientific trial program, AbbVie can be committed in order to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis plus Crohn’s illness. 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 along 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 in order to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s wellness 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 upon Twitter , Facebook , LinkedIn or Instagram .

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements pertaining to purposes associated with 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 plus uncertainties that may cause actual results to differ materially from those indicated inside the forward-looking statements. Such risks and uncertainties include, but are not limited in order to, failure to realize the particular 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 within the research and development process, undesirable litigation or even government action, changes in order to laws plus regulations applicable to our own industry and the effect of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that could affect AbbVie’s operations is set forth in Item 1A, “Risk Factors, inch of AbbVie’s 2021 Annual Report on Form 10-K, which has been filed using the Securities and Exchange Commission, as updated simply by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes simply 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:

  1. D’Haens G., et al. Risankizumab as Induction Therapy meant for Crohn’s Illness. Lancet.
  2. Ferrante M., ainsi que al. Risankizumab as Servicing Therapy designed for Crohn’s Condition. Lancet.
  3. 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 upon January 11, 2022.
  4. Crohn’s disease. Symptoms and Causes. Mayo Clinic. 2022. Offered at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304 . Accessed on January eleven, 2022.
  5. AbbVie. Data upon File: ABVRRTI71474.
  6. AbbVie. Data on File: ABBVRRI71526.
  7. AbbVie. Data on File: ABVRRTI72293.
  8. A Study of the Efficacy and Security 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.
  9. A Study in order to Assess the Effectiveness and Protection of Risankizumab in Individuals With Reasonably to Seriously Active Crohn’s Disease Who Failed Prior Biologic Therapy. ClinicalTrials. gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03104413 . Utilized on Dec 18, 2020.
  10. A Research from the Efficiency and Basic safety of Risankizumab in Participants With Crohn’s Disease. ClinicalTrials. gov. 2021. Offered at: https://clinicaltrials.gov/ct2/show/NCT03105102 . Seen May 21, 2021.
  11. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.
  12. Research 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. Offered at: https://clinicaltrials.gov/ct2/show/NCT03671148 . Accessed upon January 13, 2022.
  13. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Individuals With Somewhat to Significantly Active Ulcerative Colitis. ClinicalTrials. gov. 2022. Available from: https://clinicaltrials.gov/ct2/show/record/NCT03398148 . Accessed on January thirteen, 2022.
  14. Kaplan, G. The global problem of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec; 12(12): 720-7. Doi: ten. 1038/nrgastro. 2015. 150.
  15. The particular Economic Costs of Crohn’s Disease plus 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.
  16. Duvallet, E., Sererano, L., Assier, E., ou al. Interleukin-23: a key cytokine within inflammatory diseases. Ann Med. 2011 Nov; 43(7): 503-11.
  17. Pipeline – Our Science | AbbVie. AbbVie. 2022. Offered at: https://www.abbvie.com/our-science/pipeline.html . Reached on January 13, 2022.

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SOURCE AbbVie

Company Codes: NYSE: ABBV

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