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Regeneron : FDA Accepts Dupixent For Priority Review In Adults With Prurigo Nodularis

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said Tuesday that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application or sBLA for Dupixent Medical (dupilumab) to treat adults with prurigo nodularis.

Prurigo nodularis is a chronic skin disease that causes extreme itch and inflammatory skin lesions (nodules). The target action date for the FDA decision is September 30, 2022.

The supplemental Biologics License Application is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis. The 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 FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022.

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