Upadacitinib (RINVOQ): FDA-Approved Treatment for Rheumatoid Arthritis
The U.S. Food and Drug Administration (FDA) has approved RINVOQ (Upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR). RINVOQ is expected to be available in the U.S. from late August 2019.
The FDA approval is supported by data from the SELECT program, one of the largest Phase 3 trials in RA. Approximately 4,400 patients were evaluated across various treatment arms in five studies, including assessments of efficacy, safety, and tolerability for RA patients who failed or were intolerant to biologic DMARDs.
Types of Drugs for Treating Rheumatoid Arthritis
- NSAIDs
- Analgesics
- DMARDs (Disease-Modifying Antirheumatic Drugs)
- Glucocorticoids
- Biologics (e.g., TNF-α Antagonists, T-Cell Inhibitors, CD20 Antigen, JAK Inhibitors, Anti-IL6 Biologics)
Competition in the Rheumatoid Arthritis Drug Market
The rheumatoid arthritis drug market is highly competitive. RINVOQ (Upadacitinib) will compete with other JAK inhibitors such as Pfizer’s Xeljanz and Eli Lilly’s Olumiant. Additionally, Sanofi/Regeneron has introduced its IL-6 inhibitor, Kevzara (sarilumab), approved for RA treatment.
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