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.
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EMA Recommends New Measures For JAK Inhibitors After Confirming Serious Risks
The sponsors of five EU-approved Janus kinase inhibitors for inflammatory conditions will have to update their product information to reflect new measures and warnings from the European Medicines Agency.
Keeping Track: US FDA Okays Alnylam’s siRNA Amvuttra, Alopecia Claim For Lilly’s Olumiant; Sierra Submits Momelotinib
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Etrasimod Results Justify Pfizer’s Leap Of Faith In Arena Buyout
Detailed data presented at Digestive Disease Week show competitive efficacy in ulcerative colitis and a potential best-in-class safety profile for the S1P receptor modulator Pfizer acquired earlier this year.