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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The pharma also warns that an FDA complete response letter could be coming for its supplemental NDA to add atopic dermatitis to the JAK1 inhibitor’s label.
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.