Rinvoq FDA Approval History
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
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe rheumatoid arthritis.
Development Timeline for Rinvoq
|Aug 16, 2019||ApprovalFDA 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|
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