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What Will JAK Inhibitor Safety Jitters Mean For Drug Sales?

FDA Delays Decisions On Pfizer, Lilly/Incyte Drugs

Executive Summary

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.

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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.

AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

AbbVie Maintains Xeljanz Safety Concerns Don’t Spill Over To Rinvoq

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.

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