FDA Priority Review for upadacitinib in moderate to severe RA

19 February 2019

The Food and Drug Administration has accepted for priority review the New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis, submitted by US drugmaker AbbVie (NYSE: ABBV).

Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases.AbbVie anticipates a regulatory decision in third-quarter 2019. Notwithstanding the positive development, AbbVie’s shares initially dipped 0.57% at $80.39 shortly after markets opened this morning.

Clinical backing

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