What Will JAK Inhibitor Safety Jitters Mean For Drug Sales?
FDA Delays Decisions On Pfizer, Lilly/Incyte Drugs
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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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.
The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.
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.