Priority review for upadacitinib to treat RA

April 9, 2019 0 By FM

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.