The FDA has accepted for priority review the biologics license application (BLA) for dupilumab (Sanofi/Regeneron Pharmaceuticals, Inc.) 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 target action date of March 29, 2017.
The investigational biologic therapy inhibits signaling of interleukin (IL)-4 and IL-13, two key cytokines required for the type-2 immune response, which is believed to be major driver in the pathogenesis of the disease. According to Reuters, the product is a potential blockbuster poised to earn $3 billion per year if approved.
The BLA for dupilumab contains data from three pivotal phase 3 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.
Late-breaking data from the SOLO 1 and SOLO 2 trials will be presented at the 25th European Academy of Dermatology and Venereology Congress in October.
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.