A Phase 3 clinical trial evaluating Regeneron Pharmaceuticals (NASDAQ:
REGN) and development partner Sanofi’s (NASDAQ:
SNY) Dupixent (dupilumab), added to standard-of-care topical corticosteroids, in children aged 6 – 11 years with severe atopic dermatitis
met the primary and secondary endpoints.
At week 16, 33% of patients receiving 300 mg of Dupixent every four weeks and 30% of those receiving 100 or 200 mg of Dupixent every two weeks achieved clear or almost clear skin compared to 11% for placebo (p<0.0001 and p=0.0004, respectively).
70% of patients receiving Dupixent every four weeks and 67% of those receiving Dupixent every two weeks achieved 75% or greater skin improvement versus 27% for placebo (p<0.0001 for both).
The rates of adverse events in the Dupixent groups were 65% and 67%, respectively, compared to 73% for placebo.
Detailed results will be submitted for presentation at a future medical conference.
Dupixent is currently approved in the U.S. for adults and adolescents with atopic dermatitis or asthma and adults with rhinosinusitis with nasal polyposis.