Rinvoq bags FDA green light
AbbVie has announced the US Food and Drug Administration FDA approval of Rinvoq upadacitinib for moderate to severe active rheumatoid arthritis RA. In the SELECT programme, the oral JAK inhibitor met all primary and ranked secondary endpoints across a variety of patients with moderately to severely active rheumatoid arthritis, and significantly inhibited radiographic progression even without methotrexate. The study was one of the largest registrational Phase III programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies, which included assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naive or inadequate responders to methotrexate. Rinvoq is not indicated for methotrexate-naive patients. "Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis," said Roy M. Fleischmann, primary investigator for SELECT.