FDA Accepts sBLA for Priority Review for Dupixent in PN

FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) from Sanofi and Regeneron to treat adults with prurigo nodularis. The target action date for the FDA decision is September 30, 2022.

The sBLA is supported by data from two pivotal Phase 3 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.

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Sanofi and Regeneron say they plan additional regulatory filings outside of the US in 2022.