Posted by Michael Wonder on 19 Feb 2019
AbbVie announces new drug application accepted for priority review by U.S. FDA for upadacitinib for treatment of moderate to severe rheumatoid arthritis
19 February 2019 - AbbVie used a priority review voucher to expedite review of the upadacitinib NDA.
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases.1-13 AbbVie anticipates a regulatory decision in Q3 2019.
The NDA is supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five of six Phase 3 studies.
