Author: Anoma Ranaweera, Medical Writer. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2017.
Dupilumab (Dupixent®; Sanofi, Paris, France; Regeneron, New York, USA) is a fully human monoclonal antibody, which has shown significant efficacy and a favourable safety profile in moderate-to-severe atopic dermatitis alone and in combination with topical corticosteroids.
The U.S. Food and Drug Administration (FDA) approved Dupixent® as a treatment for moderate-to-severe atopic dermatitis in adults in March 2017 and in patients aged 12 to 17 in March 2019. It was approved by Therapeutic Goods Adminstration (TGA) in Australia in January 2018, and it was classified as a prescription medicine by Medsafe in New Zealand in March 2018.
The Biologics License Application (BLA) for dupilumab contains data from three pivotal phase 3 clinical studies evaluating dupilumab as monotherapy and in concomitant administration with topical corticosteroids.
Most common (> 5%) adverse reactions associated with dupilumab treatment in clinical trials were:
No drug-specific blood-test monitoring is required.
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