AbbVie's Rinvoq gets FDA Boxed Warning in RA treatment

US drugmaker AbbVie (NYSE: ABBV) late on Friday announced that the US regulator is requiring the labelling of its Rinvoq (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA) to now carry a Boxed Warning, as a result of safety problems that continue to impact the JAK inhibitor class of drugs.

This update follows a Drug Safety Communication (DSC) issued on September 1, 2021, by the US Food and Drug Administration following its final review of the post-marketing study, ORAL Surveillance, evaluating 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 (a Janus kinase (JAK) inhibitor) versus TNF blockers. The DSC and this label update apply to the class of systemically administered FDA-approved JAKs indicated for the treatment of RA and other inflammatory diseases.

Based on this class-wide update, the US label for Rinvoq will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections. The indication has also been updated to the following: Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.