AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderate to Severe Crohn's Disease

- 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:

1. D'Haens G., et al. Risankizumab as Induction Therapy for Crohn's Disease. Lancet.
2. Ferrante M., et al. Risankizumab as Maintenance Therapy for Crohn's Disease. 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 on January 11, 2022.
4. 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.
5. AbbVie. Data on File: ABVRRTI71474.
6. AbbVie. Data on File: ABBVRRI71526.
7. AbbVie. Data on File: ABVRRTI72293.
8. 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.
9. 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.
10. 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.
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. 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.
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. 2022. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on January 13, 2022.
14. 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.
15. 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.
16. Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
17. 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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