The Food and Drug Administration (FDA) has approved the use of Dupixent (dupilumab; Sanofi and Regeneron) to treat moderate-to-severe atopic dermatitis in adolescent patients 12–17 years old whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The approval was based on data from a phase 3 trial which showed that the treatment effect and safety profile of dupilumab in adolescent patients were generally consistent with that seen in adult trials. “Our phase 3 data demonstrated that Dupixent treatment significantly improved skin lesions, reduced itching, and helped clear the skin of these adolescent patients,” said John Reed, MD, PhD, Head of Research and Development at Sanofi.
Dupixent can be used with or without topical corticosteroids. Dosing in adolescent patients with atopic dermatitis is based on body weight (<60kg vs ≥60kg). The product is supplied as a single-dose prefilled syringe in 200mg/1.14mL and 300mg/2mL dosage strengths.
With this approval, Dupixent, an interleukin-4 receptor alpha antagonist, is now indicated for patients ≥12 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is also approved for add-on maintenance treatment in patients ≥12 years with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
For more information call (844) 387-4936 or visit Dupixenthcp.com.