Regeneron and Sanofi's Dupilumab Biologics License Application Accepted for Priority Review by FDA

Monday, September 26, 2016 | FDA Approval/Clearance , Atopic Dermatitis , Regeneron , Sanofi


The FDA has accepted for priority review the Biologics License Application (BLA) for dupilumab from Regeneron Pharmaceuticals, Inc. and Sanofi for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD). The application has been given a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017. The investigational antibody therapy dupilumab inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in the pathogenesis of the disease.  

The BLA for dupilumab contains data from three Phase 3 pivotal studies in the global LIBERTY AD program that included more than 2,500 patients. The goal of the studies was to evaluate dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS), in adult patients with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies. In 2014, the FDA granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe AD who are not adequately controlled with topical prescription therapies or for whom these treatments are not appropriate.

Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. If approved, dupilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business of Sanofi.

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