AbbVie Submits Regulatory Application to FDA for SKYRIZI® (risankizumab-rzaa) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease
Rhea-AI Summary
AbbVie (NYSE: ABBV) submitted an application to the FDA on April 27, 2026, seeking approval for SKYRIZI (risankizumab-rzaa) as a subcutaneous (SC) induction treatment for adults with moderately to severely active Crohn's disease.
The filing is supported by positive Phase 3 AFFIRM study data and would give patients an option between SC induction or the existing IV induction, continuing SC maintenance every eight weeks if approved.
Positive
- Submission backed by positive Phase 3 AFFIRM efficacy and safety data
- Offers an SC induction option alongside existing IV induction for Crohn's disease
- Potential to increase patient choice and convenience for induction dosing
Negative
- Approval timeline uncertain despite company anticipation of clearance later in 2026
- Regulatory approval depends on FDA review of AFFIRM data and may require further requests
News Market Reaction – ABBV
In the Apr 27 session, ABBV declined 0.67%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 22 | Manufacturing expansion | Positive | -1.5% | Announced new $1.4B Durham manufacturing campus to expand production capabilities. |
| Apr 14 | Brand marketing | Neutral | +1.8% | Natrelle breast augmentation campaign with influencer partnership to boost patient education. |
| Apr 13 | Licensing deal | Positive | -0.7% | Exclusive pain-medicine license from Haisco granting AbbVie global rights ex-China regions. |
| Apr 08 | Grant program | Positive | +2.5% | BOTOX Cosmetic expanded entrepreneurial grant and mentoring program for women business owners. |
| Apr 07 | Training center | Positive | -0.1% | Opened third U.S. AMI training center to advance provider education in aesthetics. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news has often shown mixed price reactions, with several operational and partnership positives met by modest declines or muted moves.
Over recent months, AbbVie announced a $1.4 billion Durham manufacturing campus, consumer-facing Allergan Aesthetics initiatives, and a pain-focused licensing deal with Haisco. These span capacity expansion, brand engagement, and pipeline diversification. Price reactions have varied, with some positive corporate developments seeing slight declines. Today’s FDA submission for subcutaneous SKYRIZI induction fits the pattern of ongoing investment in immunology and lifecycle innovation on established assets.
Key Terms
subcutaneous medical
intravenous (IV) medical
interleukin-23 (IL-23) medical
Phase 3 medical
induction medical
maintenance dosing medical
Crohn's disease medical
U.S. Food and Drug Administration (FDA) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Submission supported by data from Phase 3 pivotal AFFIRM study
- If approved, adult Crohn's disease patients will have an additional option for induction of risankizumab-rzaa which is already approved for intravenous (IV) induction
"Crohn's disease is a chronic inflammatory condition that affects an estimated 1 million Americans, and its impact often reaches beyond the gut as its unpredictability can impact daily life and emotional health for patients," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "AbbVie continues to invest in research and innovative solutions to help elevate the standard of care for patients so that they may live a life unburdened by their Crohn's disease."
The application to the FDA is supported by the recently shared positive data from the Phase 3 AFFIRM study1 (NCT06063967), which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, including both those with and without prior advanced therapy failure.
In 2022, SKYRIZI became the first interleukin-23 (IL-23) specific inhibitor approved by the FDA to treat adults with moderately to severely active CD. AbbVie anticipates FDA approval for this new dosing regimen for SKYRIZI later this year. If approved, patients with moderately to severely active CD would have a choice to receive their SKYRIZI induction via SC injection or through IV infusion and then continue subcutaneous maintenance dosing every eight weeks.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain.2,3 It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.4,5 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.6
About the AFFIRM Study1
AFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as an induction treatment in adult patients with moderately to severely active Crohn's disease. Co-primary endpoints were achievement of CDAI Clinical Remission (CDAI < 150) and achievement of endoscopic response at week 12. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups;
About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.8 SKYRIZI is approved by the
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:
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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:
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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.
This is the most important information to know about SKYRIZI. 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/PatientAccessSupport 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
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, neuroscience and oncology – 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 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, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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.
References
- AbbVie. Data on file ABVRRTI82775
- Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed February 23, 2026. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic. Accessed February 23, 2026. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
- Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
- 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.
- Gajendran M, et al. A comprehensive review and update on Crohn's disease. Dis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001.
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (AFFIRM). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06063967. Accessed February 23, 2026.
- SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025.
- SKYRIZI. Summary of Product Characteristics. AbbVie. Accessed February 23, 2026.
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Stephanie Tennessen | Liz Shea |
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