Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE. Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with Rinvoq, including: Sudden unexplained chest or upper back pain, Shortness of breath or difficulty breathing. Pipeline Our Science | AbbVie. Subscription management. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Mucosal healing was observed in 30 percent and 37 percent of patients treated with RINVOQ 45 mg in U-ACHIEVE and U-ACCOMPLISH, respectively, at week 8, compared to 7 percent and 6 percent of patients, respectively, who received placebo. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. For more information, talk to your HCP. Your HCP will check whether or not you are pregnant before you start RINVOQ. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Available at:https://clinicaltrials.gov/ct2/show/NCT02675426. This FDA approval marks the sixth indication for RINVOQ in the United States across chronic immune-mediated diseases, including four in rheumatology. Based on animal studies, RINVOQ may harm your unborn baby. Medicines for fungal or bacterial infections, Tell your HCP right away if you have any symptoms of an infection. We also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily. Symptoms and Causes. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). Medicines for fungal or bacterial infections, Tell your HCP right away if you have any symptoms of an infection. We comply with the HONcode standard for trustworthy health information. Epidemiology of axial spondyloarthritis: an update. 2021. Your HCP will check whether or not you are pregnant before you start RINVOQ. During the maintenance trial, 42 percent and 52 percent of patients treated with RINVOQ 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo. Rinvoq and other medicines may affect each other, causing side effects. Accessed onMarch 9, 2021. We also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. Use the lowest effective dosage needed to maintain response. Additional study results include the . In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications," said Atul Deodhar, M.D., professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and lead investigator of the SELECT-AXIS 2 nr-axSpA trial. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. 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 theSecurities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. The U.S. Food and Drug Administration (FDA) approved a new drug, upadacitinib (Rinvoq), for people with ankylosing spondylitis (AS), making it the second JAK inhibitor approved for AS. Privacy policy Live, have lived, or have traveled to parts of the country, such as theOhioand Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. ClinicalTrials.gov. We comply with the HONcode standard for trustworthy health information. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. All rights reserved. Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ulcerative Colitis, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis. Sign up If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Have had any type of cancer, hepatitis B or C, shingles (herpes zoster),blood clots in the veins of your legs or lungs,diverticulitis (inflammation in parts of the large intestine),or ulcers in your stomach or intestines. Subscribe for email alerts The information in the press releases on these pages was factually accurate on the date of publication. Before engaging, please read and adhere to our established community guidelines for each channel. The "Yes" link below will take you out of the AbbVie family of websites. Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as: Warm, red, or painful skin or sores on your body, Burning when urinating or urinating more often than normal. * "In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Seniors Taking Multiple Meds: Its a Complicated Problem, 3 COVID Scenarios That Could Spell Trouble for the Fall, Colonoscopy Benefits Lower Than Expected (Study), Dr. Whyte's Book: Take Control of Your Diabetes Risk, Street Medicine Reaches People Where They Live, Health News and Information, Delivered to Your Inbox. This additional indication follows the FDA approval of Rinvoq in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions.1, Nr-axSpA is a chronic, progressive inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness, and cannot be detected by x-ray.5,6 Nr-axSpA and AS are two sub-types of a broader condition called axial spondyloarthritis. In August, the U.S. Food and Drug Administration (FDA) approved upadacitinib (Rinvoq) to treat adults with moderate to severe active rheumatoid arthritis (RA) who are methotrexate intolerant or for whom methotrexate was inadequate. north chicago, ill., oct. 21, 2022 /prnewswire/ -- abbvie (nyse: abbv) today announces that the u.s. food and drug administration (fda) has approved rinvoq (upadacitinib 15 mg, once. NORTH CHICAGO, Ill., Oct. 21, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announces that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who . Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. ClinicalTrials.gov. The FDA approval decision is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of RINVOQ in adults with active nr-axSpA . Accessed onMarch 10, 2021. RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other system drug products, including biologics or when use of those therapies is inadvisable. "This approval is a significant milestone for our community, providing an additional therapy that may bring relief to those living with the devastating symptoms of moderate to severe atopic dermatitis.". 2014; 27(2): 95104. Rinvoq (upadacitinib) FDA Approval History. The FDA's new approval was based on the SELECT-AXIS 2 clinical trial, which assessed the drug's efficacy and safety in 314 adults with nr . You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Are breastfeeding or plan to breastfeed. About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies1-4 View our social media channel guidelines , AbbVie.com Do not split, crush, or chew the tablet. If you qualify, please, https://doi.org/10.1038/s41572-018-0001-z, https://www.abbvie.com/our-science/pipeline.html. Mayo Clinic. RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.4, Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, giant cell arteritis and Takayasu arteritis are ongoing.11-17, RINVOQ (upadacitinib) U.S. Use and Important Safety Information4. You are encouraged to report negative side effects of prescription drugs to the FDA. Oral Presentation OP24. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with Rinvoq and for 4 weeks after your last dose. adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. For more information, talk to your HCP. "Today's FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease. Accessed. 2019. RINVOQ is available in 15 mg and 30 mgextended-release tablets. The Internet site that you have requested may not be optimized to your screen size. RINVOQ (upadacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2019 Do nottake RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. Patients receiving the therapies will need close monitoring due to specific FDA guidelines for each dose, including titration as needed. The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. 2021. For more details, please visit AbbVie.com/myAbbVieAssist. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative. Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. ClinicalTrials.gov. 2014. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions. Have had a heart attack, other heart problems, or stroke. Danese S, et al. Follow@abbvieon Twitter,Facebook,LinkedInorInstagram. Please click here for theFull Prescribing InformationandMedication Guide. 2005 - 2022 WebMD LLC. Accessed on. Vermeire S, et al. And as an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis.". 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. A study comparing upadacitinib (ABT-494) to placebo and to adalimumab in adults with rheumatoid arthritis who are on a stable dose of methotrexate and who have an inadequate response to methotrexate (SELECT-COMPARE). 2021. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. today announces that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults . AbbVie initially sought approval from both the FDA and European Medicines Agency (EMA) for upadacitinib in June 2020. What is the most important information I should know about RINVOQ? How Does Ankylosing Spondylitis Progress. Accessed onDecember 10, 2021. 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. Approximately five percent of patients with nr-axSpA will progress to AS after five years, and 19 percent will progress after ten years.7, "This latest FDA approval of Rinvoq in active nr-axSpA provides a new oral, once-daily treatment option for patients who historically have had limited treatment options for this painful, chronic disease," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. ClinicalTrials.gov. More information about this assistance program can be found atwww.AbbVie.com/myAbbVieAssist. People who take Rinvoq should not receive live vaccines. *Emma Guttman-Yassky, M.D., Ph.D., is a researcher/consultant for AbbVie. north chicago, ill., oct. 21, 2022 /prnewswire/ -- abbvie (nyse: abbv) today announces that the u.s. food and drug administration (fda) has approved rinvoq ( upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation who have Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. Do not split, crush, or chew the tablet. If you are unsure if you've been to these types of areas, ask your HCP. Available at:https://clinicaltrials.gov/ct2/show/NCT03104400. For more information about AbbVie, please visit us atwww.abbvie.com. Patient Access and Support Sign up Nat Rev Dis Primers 4, 1 (2018). The primary endpoints were clinical remission per mMS at week 8 for the induction clinical trials and at week 52 for the maintenance trial. Among patients who received Rinvoq 15 mg, nearly half achieved an ASAS40* response, the primary endpoint, at week 14 compared to placebo (44.9 percent vs. 22.3 percent respectively).1,2 ASAS40 responses were observed as early as two weeks in nr-axSpA patients treated with Rinvoq. Available at:https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed onDecember 10, 2021. ClinicalTrials.gov identifier: NCT02629159. Overall, the safety profile observed in patients with UC treated with RINVOQ was generally similar to the safety profile in patients with RA and AD. adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. During the U-ACHIEVE and U-ACCOMPLISH induction trials at week 8, 26 percent and 33 percent of patients treated with RINVOQ 45 mg achievedclinical remission,the primary endpoint based on mMS, compared to 5 percent and 4 percent of patients who received placebo. RINVOQ is a prescription medicine used to treat: It is not known if RINVOQ is safe and effective in children under 18 years of age with juvenile idiopathic arthritis or psoriatic arthritis. The treatment is a once daily, oral Janus kinase (JAK) inhibitor and is approved in a 15 mg dose. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis. Accessed on. The "Yes" link below will take you out of the AbbVie family of websites. What should I tell my HCP BEFORE starting Rinvoq? Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Available at:https://clinicaltrials.gov/ct2/show/NCT03345836. RINVOQ and other medicines may affect each other, causing side effects. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). 2021. ECCO 2021. The FDA has approved upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to 1 or more tumor necrosis factor blockers. The FDA approval decision is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of RINVOQ in adults with active nr-axSpA. Rinvoq (upadacitinib) Consumer information. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. Available at:https://clinicaltrials.gov/ct2/show/NCT04169373. These are not all the possible side effects of RINVOQ. Have had a heart attack, other heart problems, or stroke. Globally, prescribing information varies; refer to the individual country product label for complete information. Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi's varicelliform eruption. U Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomized, double-blind, placebo-controlled, phase 3 trial. Deodhar AA, Understanding Axial Spondyloarthritis: A Primer for Managed Care. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back, Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, Pain or discomfort in your arms, back, neck, jaw, or stomach, Shortness of breath with or without chest discomfort, Weakness in one part or on one side of your body. This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies. | ", The FDA approval decision is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of Rinvoq in adults with active nr-axSpA. . The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. For more information, visit AbbVie in rheumatology. Experience the interactive Multimedia News Release here: https://www.multivu.com/players/English/8978351-abbvie-fda-ulcerative-colitis/, "There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome," said Thomas Hudson, MD, senior vice president of research and development, chief scientific officer, AbbVie. | Forward-Looking Statements 2021. Terms of use Available at:https://clinicaltrials.gov/ct2/show/NCT02819635. This area is reserved for members of the news media. For more information about AbbVie, please visit us atwww.abbvie.com. VisitAbbVie.com/myAbbVieAssistto learn more. March 16, 2022 RINVOQ (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis In clinical trials, RINVOQ (upadacitinib) achieved the primary endpoints of clinical remission (per modified Mayo Score [mMS]) at weeks 8 and 521-4 Do not breastfeed during treatment with Rinvoq and for 6 days after your last dose. ", The two induction studies (U-ACHIEVE and U-ACCOMPLISH) utilized RINVOQ 45 mg once daily for 8 weeks, and then 15 mg or 30 mg once daily for the maintenance study (U-ACHIEVE maintenance) through 52 weeks.1-4 Across all clinical trials, significantly more patients treated with RINVOQ achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS: stool frequency subscore (SFS) 1 and not greater than Baseline, rectal bleeding subscore (RBS) = 0, endoscopy subscore (ES) of 1 without friability, compared to placebo. Brand name: Rinvoq 2021. For more information about AbbVie, please visit us at www.abbvie.com. Cookie Settings. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. In the U.S., RINVOQ 15 mg and 30 mg is approved for use in adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.1 RINVOQ 15 mg is also approved in the U.S. for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. 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