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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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.
A safety study of Pfizer's anchor immunology brand Xeljanz showed higher rates of heart attacks and cancer versus a TNF inhibitor.
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.