FDA Grants Priority Review to Dupixent for Atopic Dermatitis in Adolescents
If approved for this indication, dupilumab (Dupixent) will be the first systemic biologic medicine to treat adolescents with moderate-to-severe atopic dermatitis.
Officials with the FDA have granted Priority Review to dupilumab (Dupixent, Sanofi) for moderate-to-severe atopic dermatitis in adolescent patients aged 12 to 17 years, according to a press release.
If approved by the FDA for this indication, dupilumab will be the first systemic biologic medicine to treat adolescents with moderate-to-severe atopic dermatitis, according to Sanofi.
Dupilumab is currently approved in the United States as a treatment 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. In October 2018, the FDA approved dupilumab for use as an add-on maintenance therapy for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Sanofi submitted its supplemental Biologics License Application based on phase 3 data evaluating the efficacy and safety of dupilumab monotherapy in adolescent patients.
The trial enrolled 251 patients who were aged 12 to 17 years old with moderate-to-severe atopic dermatitis whose disease could not be adequately controlled with topical medication or for whom topical treatment was medically inadvisable. According to the data, treatment with dupilumab as a monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures in adolescents over 16 weeks.
The patients were randomized into 1 of 3 treatment groups: the first group was treated with dupilumab subcutaneous injection 200 mg or 300 mg every 2 weeks, the second group was treated with 300 mg dupilumab every 4 weeks with an initial dose of 600 mg, and the third group was treated with placebo every 2 weeks.
According to the results:
- 24% of patients who received weight-based dosing of dupilumab every 2 weeks (200 mg or 300 mg) and 18% of patients who received a fixed dose of dupilumab every 4 weeks (300 mg) achieved the primary endpoint of clear or almost-clear skin, compared with 2% with placebo.
- 41.5% of patients who received dupilumab every 2 weeks and 38% of patients who received dupilumab every 4 weeks achieved 75% or greater skin improvement compared with 8% with placebo.
- There was a 66% improvement in the group who received dupilumab every 2 weeks and a 65% improvement in the group that received dupilumab every 4 weeks in average percent change from baseline Eczema Area and Severity Index score compared with a 24% improvement in the placebo group.
- There was a 48% improvement in the group who received dupilumab every 2 weeks and a 45.5% improvement in the group who received dupilumab every 4 weeks in average percent change baseline in the pruritus numerical rating scale compared with a 19% improvement in the placebo group.
The target action date for the FDA decision is March 11, 2019, according to the release.
FDA grants priority review for Dupixent (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis [news release]. Sanofi’s website. https://bit.ly/2SRkuf2. Accessed November 6, 2018.