The U.S. Food and Drug Administration (FDA) has approved AbbVie’s 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 FDA approval of RINVOQ is supported by data from the SELECT program, one of the largest registrational Phase 3 programs in RA with approximately 4400 patients evaluated across all treatment arms in five studies.
The studies include 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 naïve or inadequate responders to methotrexate. RINVOQ is not indicated for methotrexate-naïve patients.
Across the SELECT Phase 3 studies, RINVOQ met all primary and ranked secondary endpoints. The primary endpoints include:
- In SELECT-EARLY, 52% of MTX-naïve patients treated with RINVOQ 15 mg achieved ACR50 vs 28% treated with MTX at week 121
- In SELECT-MONOTHERAPY, 68% of MTX-IR patients treated with RINVOQ 15 mg achieved ACR20 vs 41% treated with continued MTX at week 141
- In SELECT-COMPARE, 71% of MTX-IR patients treated with RINVOQ 15 mg plus MTX achieved ACR20 vs 36% treated with placebo plus MTX at week 121
- In SELECT-NEXT, 64% of csDMARD-IR patients treated with RINVOQ 15 mg plus csDMARDs achieved ACR20 vs 36% treated with placebo plus csDMARDs at week 121
- In SELECT-BEYOND, 65% of biologic-IR patients treated with RINVOQ 15 mg plus csDMARDs achieved ACR20 vs 28% treated with placebo plus csDMARDs at week 121.
Dr Roy M. Fleischmann, primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas, said: “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.
“With this FDA approval, RINVOQ has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”
Dr Michael Severino, vice chairman and president, AbbVie, said: “This FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis.”