US FDA Grants Dupixent Priority Review for Moderate-to-Severe AD in Adolescents

November 5, 2018

The US Food and Drug Administration (FDA) has granted Priority Review for Dupixent (dupilumab) as a potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis (AD).

Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe AD. The target action date for the FDA decision is March 11, 2019.

The supplemental Biologics License Application (sBLA) is supported by data from a pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent monotherapy in adolescent patients with moderate-to-severe AD, which were presented at the European Academy of Dermatology and Venereology in September 2018.

Dupixent inhibits interleukin-4 and interleukin-13 (IL-4 and IL-13) signaling, which is one of the important contributors to Type 2 inflammation, a systemic response known to play a role in moderate-to-severe AD. Dupixent is currently approved in the U.S. as a treatment for adults with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; and as add-on maintenance treatment for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of moderate-to-severe (adolescents 12 to 17 years of age) and severe (children 6 months to 11 years of age) AD not well controlled on topical prescription medications.

Dupixent is also approved for use in certain adult patients with moderate-to-severe AD in countries of the European Union, and other countries including Canada and Japan. In the U.S., more than 60,000 adult patients with atopic dermatitis have been prescribed Dupixent to date. The safety and efficacy of Dupixent in adolescents with atopic dermatitis have not been fully evaluated by any regulatory authority.

Dupilumab Development Program

Regeneron and Sanofi are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other Type 2 inflammation, including pediatric (6 months to 11 years of age) atopic dermatitis (Phase 3), pediatric asthma (Phase 3), chronic rhinosinusitis with nasal polyps (Phase 3), eosinophilic esophagitis (Phase 2/3), grass allergy (Phase 2) and peanut allergy (Phase 2). A future trial is planned for chronic obstructive pulmonary disease. Dupixent is also being studied in combination with REGN-3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab was discovered using Regeneron's proprietary VelocImmune® technology that yields optimized fully human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.



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