Dupixent given priority review for prurigo nodularis by FDA.- Regeneron + Sanofi
The FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab), from Regeneron + Sanofi, to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions.
The target action date for the FDA decision is September 30, 2022.
The sBLA is supported by data from two pivotal Phase III trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis (PRIME2 and PRIME). Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in atopic dermatitis. The adverse event more commonly observed with Dupixent was conjunctivitis.
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