PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF, SNY) announced Monday that the U.S. Food and Drug Administration has accepted Dupilumab Biologics License Application or BLA for priority review.
Dupilumab's BLA is for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis or AD, a serious, chronic inflammatory skin disease.
The application has been given a Prescription Drug User Fee Act or 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.
Regeneron said 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 and in concomitant administration with topical corticosteroids.
In 2014, the FDA granted Breakthrough Therapy designation to dupilumab.
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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