Pfizer's Xeljanz Post-Marketing Study Raises Safety Alarms
A safety study of Pfizer's anchor immunology brand Xeljanz showed higher rates of heart attacks and cancer versus a TNF inhibitor.
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Pfizer, AbbVie and Lilly will face new safety restrictions on Xeljanz, Rinvoq and Olumiant. Indication expansion remains uncertain, while first-line use appears out of the question.
Only top-line data were released by Pfizer, and the safety of abrocitinib, like other JAK inhibitors, could remain an issue.
Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.