Revised SPC: Dupixent (dupilumab) solution for injection- all presentations

SPC updated with clinical trial safety data. In study AD-1539, treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in 8.4 % on dupilumab-vs. 0 % on placebo with median eosinophil counts declining below baseline at end of treatment period.

SPS commentary:

Study AD-1652 in 367 patients aged 6 to 11 years of age with severe atopic dermatitis (AD) and Study AD-1539 in 161 patients aged 6 months to 5 years with moderate-to-severe AD reports safety profile of dupilumab with concomitant topical corticosteroids through week 16 was similar to safety profile from studies of adults and adolescents with AD.

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