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.
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Responding to Pfizer post-marketing data indicating risk for CV events or cancer in patients taking Xeljanz, AbbVie tells Q4 earnings call that a more selective JAK inhibitor like Rinvoq will offer better safety.
Keeping Track: Disappointment For Mesoblast And Aquestive; Opdivo/Yervoy Add Mesothelioma Claim; Pediatric Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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.