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Rinvoq FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 15, 2021.

FDA Approved: Yes (First approved August 16, 2019)
Brand name: Rinvoq
Generic name: upadacitinib
Dosage form: Extended-Release Tablets
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis and psoriatic arthritis.

  • Rinvoq works by blocking the activity of Janus kinase enzymes in the JAK-STAT signaling pathway, an intracellular pathway that plays a major role in the release of the pro-inflammatory cytokines that stimulate inflammation in rheumatoid arthritis and psoriatic arthritis.
  • Rinvoq is indicated for the treatment of:
    • adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
    • adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
  • Rinvoq extended-release tablets are administered orally once daily.
  • Rinvoq carries a boxed warning for the risk of serious infections, an increased rate of all-cause mortality, malignancies, adverse cardiovascular events, and thrombosis.
  • Adverse reactions include upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, and acne.

Development Timeline for Rinvoq

DateArticle
Dec 14, 2021Approval  Rinvoq (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis
Aug 16, 2019Approval  FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis
Jun 12, 2019New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR
Feb 19, 2019AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
Dec 20, 2018AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis
Oct 23, 2018AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data
Oct 22, 2018Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis
Sep 13, 2018AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress
Jun  5, 2018Upadacitinib Monotherapy Meets All Primary and Ranked Secondary Endpoints Versus Methotrexate in a Phase 3 Study in Rheumatoid Arthritis
Apr  9, 2018Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis
Feb 16, 2018AbbVie Announces New Phase 2 Data for Upadacitinib Showing Clinical and Endoscopic Outcomes in Crohn's Disease at 52 Weeks
Jan  8, 2018AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis
Dec 20, 2017AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints
Sep 11, 2017AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis
Sep  7, 2017AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis
Jun  7, 2017AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Phase 3 Study in Rheumatoid Arthritis

Further information

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