PFE - AbbVie updates U.S. labeling info for RINVOQ in rheumatoid arthritis

Following a Drug Safety Communication (DSC) issued by the FDA after the review of the post-marketing study for Pfizer’s (NYSE:PFE) XELJANZ (tofacitinib) in rheumatoid arthritis (RA), AbbVie (NYSE:ABBV) has revised its U.S. label for its JAK inhibitor RINVOQ. The update, related to drug’s prescribing information for adults with moderate to severe RA, includes additional information about the risks of malignancy and thrombosis. It also adds mortality and MACE (cardiovascular death, myocardial infarction, and stroke) risks within the Boxed Warnings and Warnings and Precautions sections. The indication has also been revised to reflect that RINVOQ also called upadacitinib is indicated for adults with moderately to severely active RA, who had an insufficient response or intolerance to one or more TNF blockers. Other JAK inhibitors include Olumiant (baricitinib), developed Incyte (NASDAQ:INCY) and licensed to Eli Lilly (NYSE:LLY), Read: When the updated warnings on JAK inhibitors were announced by the FDA in early September,

For further details see:

AbbVie updates U.S. labeling info for RINVOQ in rheumatoid arthritis