AbbVie Submits New Drug Application to U.S. FDA and Marketing Authorization Application to EMA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis

Author's Avatar
Dec 20, 2018
Article's Main Image

- Regulatory applications supported by robust SELECT Phase 3 program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis[1-5]

- In the SELECT program, results showed that upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, both as a monotherapy and in combination with conventional synthetic DMARDs[1-5]

- Upadacitinib, an investigational oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis and across multiple immune-mediated diseases[1-13]

PR Newswire