Adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies.
Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling.
600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week.
Approval was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 (n=671) and SOLO 2 (n=708) trials showed 36-38% of patients who received dupilumab had scores of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%) (P<0.001). Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P<0.001).
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.