JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety
After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.
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Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.
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.
Company is ‘anxious to understand’ how to utilize the agency’s views on importance of biomarkers, exec notes in earnings call. Merck & Co. and Pfizer advance COVID-19 therapeutics into Phase III. Pfizer is awaiting FDA risk-benefit assessment of JAK-1 inhibitors Xeljanz and abrocitinib.