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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US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks
Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.
Bouncing back from the pandemic more strongly than its peers, AbbVie sees 40% growth for Botox and Juvederm, a good launch for Ubrelvy and continued strength from its mainstays.
Patient-Focused Meeting On Vitiligo Could Galvanize R&D As The First Drug Candidates In A Long Time Advance
US FDA meeting directs attention to the vitiligo patient experience as a small group of potential treatments, led by topical Janus kinase inhibitors, are at the Phase II hinge point.