AbbVie receives approval of an oral JAK inhibitor for rheumatoid arthritis

AbbVie announced that the U.S. Food and Drug Administration (FDA) has now approved its new therapy for adults with moderately to severely active rheumatoid arthritis (RA).

The FDA approval of RINVOQ, a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, 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. 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.

“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, M.D., primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas. “With this FDA approval, RINVOQ has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”

“The discovery and development of RINVOQ is indicative of AbbVie’s long-standing commitment to advancing the science for people living with immune-mediated conditions,” said Michael Severino, M.D., vice chairman and president, AbbVie. “The FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis.”

While the approval of Rinvoq is good news for AbbVie, the class of drugs may have some safety concerns. Pfizer has also seen some concerns for its JAK inhibitor, Xeljanz (tofacitinib). Earlier this year a post-marketing study raised concerns about pulmonary embolisms for 10mg doses of the RA drug.

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