Paris, France, and Tarrytown, N.Y. – September 26, 2016 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease. The application has been given a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017. The investigational biologic 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 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.
Sanofi and Regeneron will host an Investor Relations Thematic Conference Call for the financial community focusing on Dupilumab following the late breaking data presentation from two trials evaluating dupilumab for inadequately controlled moderate-to-severe AD (SOLO 1 and SOLO 2) at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria on Saturday, October 1 at 7:00 am ET/1:00 pm CET. To access this call, dial (888) 771-4371 (U.S.), 0805 102 604 (France), or 0808 238 9578 (UK). The conference call will include a presentation followed by a Q&A session.
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 unit of Sanofi.