Question · Q4 2025
Madeline Kern asked if pre-NDA discussions with the FDA for povorcitinib in HS included the potential to include biologic-naive patients in the labeled indication.
Answer
Steven Stein, CMO, confirmed that the povorcitinib HS study included both prebiologic and postbiologic populations, demonstrating activity in both. He reiterated strong HiSCR response rates, pain control, and draining tunnel data, and stated that Incyte is seeking a label that covers both patient populations.
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