Posted by Michael Wonder on 16 Aug 2019
AbbVie receives FDA approval of Rinvoq (upadacitinib), an oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis
16 August 2019 - Approval supported by efficacy and safety data from one of the largest registrational Phase 3 programs in rheumatoid arthritis with approximately 4,400 patients evaluated across five studies.
AbbVie today announced that the U.S. FDA has approved Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.
Rinvoq is expected to be available in the U.S. in late August 2019.
The FDA approval of Rinvoq is supported by data from the SELECT program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies.
