Oral Dosing May Not Be Enough To Win Speedy Adoption Of Pfizer’s RA Pill Xeljanz
Pfizer’s newly approved oral RA therapy Xeljanz has an oral advantage over established immune modulators, which all are delivered by needle, but safety questions may slow its adoption.
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Pfizer’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks
The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.
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.
Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class
Analyst speculates that risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.