The United States Food and Drug Administration (FDA) has granted approval to AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, for its RINVOQ (upadacitinib), a 15mg, once-daily oral Janus kinase (JAK) inhibitor, it was reported on Friday.

The product is intended for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It is likely to be offered in the United States in late August 2019.

The approval of the product is supported by data from the SELECT program, one of the largest Phase 3 programs in rheumatoid arthritis with around 4,400 patients assessed across all treatment arms in five studies. The studies cover evaluations of efficacy, safety and tolerability across a variety of rheumatoid arthritis patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate. The product is not indicated for methotrexate-naive patients.