NORTH CHICAGO, Illinois., February 28, 2022 /PRNewswire/ — AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has extended its review period for SKYRIZI® (risankizumab-rzaa) for treatment of moderate to severe Crohn’s disease in patients aged 16 and over.
The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to review additional data submitted by AbbVie, including on-body injector information, for this proposed new indication. Indications currently approved for SKYRIZI are not affected by this extension.
SKYRIZI was approved in the United States in 2019 to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Earlier this year, the FDA approved SKYRIZI to treat active psoriatic arthritis in adults.1
SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and commercialization of SKYRIZI globally.
About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.1.2 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.2 SKYRIZI is approved in the United States to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and to treat active psoriatic arthritis in adults.1 Phase 3 trials of SKYRIZI in psoriasis, Crohn’s disease, ulcerative colitis and psoriatic arthritis are ongoing.3-11
Uses of SKYRIZI in the United States and Important Safety Information1
SKYRIZI is a prescription medicine used to treat adults with:
- Moderate to severe plaque psoriasis that may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
- Active psoriatic arthritis (PsA).
What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription drug that can cause serious side effects, including:
Serious allergic reactions: Stop using SKYRIZI and get emergency help right away if you have any of the following symptoms of a serious allergic reaction:
- Fainting, dizziness, lightheadedness (low blood pressure)
- Swelling of the face, eyelids, lips, mouth, tongue or throat
- Difficulty breathing or tightness in the throat
- Chest tightness
- Rash, hives
Infections: SKYRIZI may reduce your immune system’s ability 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 tuberculosis before starting treatment with SKYRIZI if you have a history of tuberculosis or if you have active tuberculosis. Your healthcare provider should monitor you closely for signs and symptoms of tuberculosis during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an infection or show symptoms of an infection, including:
- fever, sweats, or chills
- muscle aches
- hot, red, or painful skin or sores on your body that are different from your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when urinating or urinating more often than normal
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.
Before using SKYRIZI, tell your healthcare provider about all your medical conditions, including if you:
- have any of the conditions or symptoms listed in the “What is the most important information I should know about SKYRIZI?”
- have an infection that does not go away or keeps coming back.
- have tuberculosis or have been in close contact with someone who has tuberculosis.
- have recently received or plan to receive an immunization (vaccine). Medicines that interact with the immune system can increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines immediately before, during or immediately after treatment with SKYRIZI. Tell your health care provider that you are taking SKYRIZI before getting any vaccine.
- are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
- are breastfeeding or planning to breastfeed. It is not known if SKYRIZI passes into your breast milk.
Tell your health care provider about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI can cause serious side effects. See “What is the most important information I should know about SKYRIZI?”
The most common side effects of SKYRIZI include upper respiratory tract infections, feeling tired, fungal skin infections, headaches, and injection site reactions.
These are not all possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare professional has told you.
SKYRIZI is available as a 150 mg/mL pre-filled syringe and as a pen.
This is the most important information you need to know about SKYRIZI. For more information, talk to your HCP.
We encourage you to report negative side effects of prescription drugs to the FDA. To visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medications, AbbVie may be able to help. To visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for the Full Prescribing Information and Medication Guide for SKYRIZI.
Globally, prescribing information varies; refer to each country’s product label for complete information.
AbbVie’s mission is to discover and deliver innovative medicines that solve the serious health problems of today and meet the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives in several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition products and services from its Allergan Aesthetics portfolio. For more information about AbbVie, visit www.abbvie.com. Follow @abbvie on TwitterFacebook, LinkedIn or Instagram.
Certain statements in this press release are, or may be deemed to be, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe”, “expect”, “anticipate”, “project and similar expressions, among other things, 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. These risks and uncertainties include, but are not limited to, the failure to realize the anticipated benefits of the acquisition of Allergan plc by AbbVie (“Allergan”), the failure to quickly and effectively integrate the businesses of Allergan, competition from other products, intellectual property challenges, difficulties inherent in the research and development process, adverse litigation or government action, changes in laws and regulations applicable to our industry and the impact public health epidemics, epidemics or pandemics, such as COVID-19. Additional information about economic, competitive, governmental, technological and other factors that could affect AbbVie’s operations is set forth in Section 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 publicly release any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
- SKYRIZI (risankizumab) [Package Insert]. North of Chicago, Illinois.: AbbVie inc.
- Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Anne-Med. 2011 Nov;43(7):503-11.
- BI 655066 (risankizumab) compared to placebo and an active comparator (ustekinumab) in patients with moderate to severe chronic plaque psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02684370. Consulted the February 25, 2022.
- BI 655066 versus placebo and active comparator (Ustekinumab) in patients with moderate to severe chronic plaque psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02684357. Consulted the February 25, 2022.
- BI 655066/ABBV-066 (risankizumab) in moderate to severe plaque psoriasis with random withdrawal and retreatment. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02672852. Consulted the February 25, 2022.
- BI 655066/ABBV-066 (risankizumab) compared to the active comparator (adalimumab) in patients with moderate to severe chronic plaque psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02694523. Consulted the February 25, 2022.
- A study of the efficacy and safety of risankizumab in participants with moderately to severely active Crohn’s disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Consulted the February 25, 2022.
- A study to assess the efficacy and safety of risankizumab in participants with ulcerative colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03398135. Consulted the February 25, 2022.
- A multicenter, randomized, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderate to severe active ulcerative colitis. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148. Consulted the February 25, 2022.
- BI 655066/ABBV-066/Risankizumab compared to placebo in patients with active psoriatic arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308. Consulted the February 25, 2022.
- BI 655066/ABBV-066/ A study comparing risankizumab with placebo in participants with active psoriatic arthritis, including those with a history of inadequate response or intolerance to biological treatment(s) . Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed February 25, 2022.