Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). 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 March 2017. 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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