Trials & Filings

FDA Approves AbbVie’s New RA Drug

Approximately 30 percent of patients treated with RINVOQ achieved clinical remission at week 12 and week 14

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By: Kristin Brooks

Managing Editor, Contract Pharma

AbbVie received approval from the U.S. FDA for RINVOQ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR). RINVOQ is expected to be available in the U.S. in late August 2019. The approval is supported by data from the SELECT program, one of the largest registrational Phase III programs in RA with approximately 4...

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