Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD).
The accepted BLA contains results from three Phase 3 studies in the global LIBERTY AD program that enrolled >2,500 patients. The studies’ aim was to evaluate dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS), in adults with moderate-to-severe AD whose disease was not adequately controlled with topical prescription therapies.
Dupilumab is an investigational antibody therapy that inhibits signaling of IL-4 and IL-13, two major cytokines required for the type 2 (including Th2) immune response. It was granted Breakthrough Therapy designation in 2014 for the treatment of adults with moderate-to-severe AD who were not adequately controlled with topical prescription treatments or for whom these treatments are not appropriate.
The BLA has been given a Prescription Drug User Fee Act (PDUFA) target date of March 29, 2017. If approved, dupilumab will be jointly commercialized by Regeneron and Sanofi Genzyme.