Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable.
The sBLA included data from a Phase 3 trial that (N=251) evaluated the safety and efficacy of Dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis. Study patients were assigned to Dupixent 200mg or 300mg every 2 weeks (weight-based dosing); Dupixent 300mg every 4 weeks (fixed dosing); or placebo every 2 weeks for 16 weeks. The trial’s primary endpoint was the proportion of patients achieving Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). Results showed that 24% of patients who received Dupixent every 2 weeks (weight-based dosing) and 18% of patients who received Dupixent every 4 weeks (fixed dosing) achieved IGA score of 0 or 1 vs 2% of patients who received placebo (P <.001).
Dupixent, an interleukin-4 alpha antagonist, is currently approved to treat 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 with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of March 11, 2019. Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.
For more information call (800) 633-1610 or visit Dupixent.com.