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# Priority Review for AbbVie JAK1-selective Inhibitor
- URL: https://www.fdaweb.com/priority-review-for-abbvie-jak1-selective-inhibitor/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143413

FDA has accepted for priority review an AbbVie NDA for upadacitinib and its use in treating adult patients with moderate to severe rheumatoid arthritis. The investigational once-daily oral JAK1-selective inhibitor is being studied for multiple immune-mediated diseases. The company expects a review decision in the third quarter.

The submission is based on data from the company’s global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis in five Phase 3 studies, AbbVie says. Upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections, it says.