The FDA has accepted Sanofi’s supplemental biologics license application (sBLA) for priority review of dupilumab (Dupixent) in patients aged 12 to 17 years with moderate-to-severe atopic dermatitis.
The US Food and Drug Administration (FDA) has accepted Sanofi’s supplemental biologics license application (sBLA) for priority review of dupilumab (Dupixent) in patients aged 12 to 17 years with moderate-to-severe atopic dermatitis. Indications for the adolescent patient population also include those whose disease has not been fully controlled with topical therapies or for whom topical treatment was not medically advised.
Data from a phase 3 trial assessing the safety and efficacy of dupilumab in adolescent patients with moderate-to-severe atopic dermatitis served as the basis for the sBLA. The proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) served as the primary endpoint.
According to the data, patients experienced a significant improvement in signs and symptoms of atopic dermatitis and certain quality of life measures.
Specifically, 75% or greater skin improvement (EASI-75) was achieved in 41.5% of patients administered dupilumab every 2 weeks and 38% of patients administered every 4 weeks compared to 8% administered placebo (P <.001).
The primary endpoint was achieved by 24% of patients administered weight-based dosing of dupilumab every 2 weeks (200 mg or 300 mg) and 18% of patients administered a fixed dose of dupilumab every 4 weeks (300 mg) compared with 2% administered placebo (P <.001).
In the group administered dupilumab every 2 weeks, a 66% improvement was observed, and in the group administered dupilumab every 4 weeks, a 65% improvement was observed in average percent change from baseline in EASI score compared with a 24% improvement in the placebo group (P <.001).
Additionally, in the group administered dupilumab every 2 weeks, a 48% improvement was observed while a 45.5% improvement was observed in the group administered dupilumab every 4 weeks group in average percent change from baseline in the pruritus numerical rating scale compared with a 19% improvement in the placebo group (P <.001).
The supporting data was presented at the European Academy of Dermatology and Venereology in September 2018.
“Dupilumab is an exciting biologic for us in the asthma world, because it targets 2 different kinds of cytokines: interleukin (IL) 4 and 13,” Monica Kraft, MD, department of Medicine Chair at the University of Arizona College of Medicine in Tuscon, Arizona said in an interview with MD Magazine®. “Because they share a common receptor, the alpha 4 receptor, and so by targeting that receptor, you get both.”
“Why does that matter?” Kraft continued. “IL-4 is really important in the allergic response, in IgE (immunoglobulin E) formulation, and that side of things. IL-13 has a lot of effects on the airway, in terms of collagen deposition. It affects smooth muscle, increases contraction of smooth muscle, increases production of mucus—all the things that are abnormal in the asthmatic airway”.
To date, there are no systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis that are approved by the FDA.
Dupilumab is currently approved in the United States for the treatment of for adults with moderate-to-severe atopic dermatitis 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.