AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis

Friday, August 16, 2019 General News
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- RINVOQ (upadacitinib) met all primary and ranked secondary endpoints across a variety of patients with moderately to severely active rheumatoid arthritis[1-7]

References

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1 RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

2 Smolen J. et al. Upadacitinib as monotherapy: a phase 3 randomized controlled double-blind study in patients with active rheumatoid arthritis and inadequate response to methotrexate. Presented at 2018 European League Against Rheumatism (EULAR) Annual Meeting; June 13-16, 2018; Amsterdam, Netherlands.

3 Fleischmann R, et al. A phase 3, randomized, double-blind study comparing upadacitinib to placebo and to adalimumab, in patients with active rheumatoid arthritis with inadequate response to methotrexate. Presented at 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, Ill

4 Burmester GR, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.

5 Genovese MC, et al. Upadacitinib (ABT-494) in patients with active rheumatoid arthritis and inadequate response or intolerance to biological DMARDs: a phase 3 randomized, placebo-controlled, double-blind study of a selective JAK1 inhibitor. Presented at 2018 European League Against Rheumatism (EULAR) Annual Meeting; June 13-16, 2018; Amsterdam, Netherlands.

6 van Vollenhoven, et al. A phase 3, randomized, controlled trial comparing upadacitinib monotherapy to MTX monotherapy in MTX-naïve patients with active rheumatoid arthritis. Presented at 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, Ill.

7 AbbVie. Data on File. ABVRRTI68885

8 Chowdhury B. Center for Drug Evaluation and Research Summary Review of Regulatory Action Application Number: 203215Orig1s000. November 6, 2012. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000SumR.pdf

9 Okada, S. Clinical Review of Complete Response. BLA 125276/0/64. CDER/ODEII/DAARP. December 11, 2009. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000MedR.pdf

10 AbbVie. Data on File. ABVRRTI68564

11 Arthritis Foundation. What is Rheumatoid Arthritis.  Available at: https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed on July 9, 2019

12 Hunter T, et al. Rheumatology International. Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014. April 2017.

13 American College of Rheumatology. Rheumatoid Arthritis. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis. Accessed on June 7, 2019.



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