Priority review for upadacitinib to treat RAApril 9, 2019
AbbVie said the US FDA has accepted upadacitinib for priority review 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.
The new drug application is supported by data from the global upadacitinib SELECT phase 3 rheumatoid arthritis programme evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five of six phases 3 studies. In all SELECT phase 3 studies, upadacitinib met all primary and ranked secondary endpoints.
Upadacitinib is also under review by the European Medicines Agency for the same indication.
The SELECT phase 3 rheumatoid arthritis programme evaluates more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies, five of which support a regulatory submission for upadacitinib.