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