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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Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Together with a similar delay for AbbVie’s Rinvoq, the delays appear to stem from a study that raised concerns about the class. But the potential sales impact is less clear.
April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use
While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.