AbbVie Adds New Warning To Rinvoq (JAK Inhibitor) Label For Rheumatoid Arthritis

AbbVie Inc ABBV announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for rheumatoid arthritis (RA). 

• The update follows a Drug Safety Communication (DSC) issued in September by the FDA following its final review of the post-marketing study, evaluating Pfizer Inc's PFE Xeljanz (tofacitinib) in patients with RA.
• The results of this study showed a higher rate of major adverse cardiac events (MACE), malignancy, mortality, and thrombosis in Xeljanz (Janus kinase (JAK) inhibitor) versus TNF blockers.
• Related Link: FDA Hits JAK inhibitors With Heart Safety, Cancer Warnings: All You Need To Know.
• Rinvoq and Xeljanz are now recommended for use only in patients who have had inadequate response or intolerance to one or more TNF blockers, another class of drugs used against inflammatory conditions.
• The DSC and label update applies to the class of systemically administered FDA-approved JAKs indicated for the treatment of RA and other inflammatory diseases.
• As a result of a recent readout, AbbVie put out a notice that it is adding the new class risks to its label.
• Supplemental applications for upadacitinib in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis remain under review by the FDA.  
• See here Benzinga's Full FDA Calendar.
• Price Action: ABBV shares are up 0.53% at $119.48 during the premarket session on Monday's last check.