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

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.