FDA Expands Indications for DupixentMarch 13, 2019
The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Dupixent (dupilumab; Sanofi and Regeneron Pharmaceuticals Inc.) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 to 17 years whose disease is not controlled with topical prescription therapies or when those therapies are not advisable. Dupixent was previously FDA approved for the treatment of adult patients with moderate-to-severe atopic dermatitis and for use as an add-on maintenance treatment in patients with moderate-to-severe asthma.
Dupixent is a targeted biologic therapy (interleukin-4 receptor alpha antagonist) administered by subcutaneous injection every other week. The expanded FDA approval was based on results from a randomized placebo-controlled trial, which demonstrated that the use of Dupixent resulted in clear or almost clear skin as well as reduced pruritus compared with placebo in adolescent patients.
Regeneron Pharmaceuticals Inc. FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents [news release]. March 11, 2019. Available at: click here. Accessed March 13, 2019.