SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis
AbbVie announced the launch of SKYRIZI® (risankizumab-rzaa) in the U.S. as a 150 mg single-dose injection for adults with moderate to severe plaque psoriasis. This new formulation reduces the administration frequency from two 75 mg injections to one 150 mg injection every 12 weeks after two starter doses. The FDA approved this dosage change based on clinical trials showing it offers the same efficacy and safety as the previous method. This innovation aims to enhance patient experience, reducing the number of injections required annually.
- The introduction of a single-dose 150 mg SKYRIZI significantly improves patient convenience with only four injections needed per year.
- FDA approval based on solid clinical data validates the efficacy and safety of the new dosage.
- None.
NORTH CHICAGO, Ill., Aug. 9, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that SKYRIZI® (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, is now available in the U.S. as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis. Previously two 75 mg injections per dose, SKYRIZI 150 mg is now administered with one injection per dose – via either a prefilled pen or syringe – every 12 weeks following two starter doses.1
The new SKYRIZI 150 mg pen incorporates wide grip handles, audible cues to help guide the administration process and an indicator to signal when administration is complete.
"We know many people living with psoriasis are looking for flexibility in how they manage their disease," said Patrick Horber, President, U.S. Immunology, AbbVie. "That's why we're proud to provide an updated SKYRIZI treatment experience that allows for fewer injections of the same SKYRIZI that patients and providers have come to know and trust."
The U.S. Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile.
"Helping my psoriasis patients find an ideal treatment option for them requires not only assessment of the plaques on their skin, but consideration of a treatment experience that fits their lifestyle," said Lindsay Ackerman, M.D., board-certified dermatologist and founder of Medical Dermatology Specialists in Phoenix, AZ. "The single-dose injection options for SKYRIZI 150 mg allow for a maintenance treatment plan of only four injections per year and are a welcome addition to the psoriasis treatment mix."
SKYRIZI is part of a collaboration with Boehringer Ingelheim, with AbbVie leading development and commercialization of SKYRIZI globally.
About Psoriasis
Psoriasis is a chronic, immune-mediated, inflammatory skin condition that produces thickened, scaling skin due to rapid growth of skin cells.2 It affects an estimated 7.5 million people in the U.S.,3 with approximately 80-90 percent having plaque psoriasis.2 People with psoriasis also experience a significant emotional, psychological and social burden that can negatively impact their quality of life.4
About SKYRIZI® (risankizumab-rzaa) in the United States1
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information1
What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?
SKYRIZI may cause serious side effects, including infections. SKYRIZI is a prescription medicine that 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:
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when you urinate or urinating more often than normal
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). Medications 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.
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?"
The most common side effects of SKYRIZI include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.
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 is available in a 150 mg/mL prefilled syringe and pen.
This is not a complete summary of all safety information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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/myAbbVieAssist to learn more.
Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.
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 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 its 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 Statement
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 2020 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:
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- AAD. Psoriasis: Overview. https://www.aad.org/public/diseases/psoriasis/what/overview. Accessed July 26, 2021.
- National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis/. Accessed July 26, 2021.
- National Psoriasis Foundation. Statistics. https://www.psoriasis.org/content/statistics. Accessed July 26, 2021.
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SOURCE AbbVie
FAQ
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