Sanofi and Regeneron’s Dupixent sBLA for Prurigo Nodularis Gets FDA Priority Review

The FDA has granted Sanofi and Regeneron’s blockbuster monoclonal antibody Dupixent (dupilumab) a priority review for its supplemental Biologics License Application (sBLA) for the treatment of patients with the skin disease prurigo nodularis.

The sBLA is supported by two late-stage clinical trials in which Dupixent showed significant improvements in symptoms compared to placebo, including reduced itching and skin lesions.

Sales of Dupixent exceeded $6 billion in 2021. The drug is currently approved for several indications, including most recently for treatment of patients with eosinophilic esophagitis, an allergic condition in the esophagus.

The FDA’s target decision date for the sBLA is Sept. 30.