Dupilumab

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 is an innovative first-in-class investigational biologic agent for atopic dermatitis (eczema).

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) granted Dupixent® Breakthrough Therapy designation in uncontrolled moderate-to-severe atopic dermatitis in 2014.

The Biologics License Application (BLA) for dupilumab was recently accepted for Priority Review by the U.S. FDA with a target action date of March 29, 2017, for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The BLA contains data from three pivotal phase 3 clinical studies evaluating dupilumab as monotherapy and in concomitant administration with topical corticosteroids.

What is dupilumab used for?

How does dupilumab work? 

Dosage and administration

Link to key clinical-trial evidence about dupilumab

What are the adverse effects of dupilumab?

Most common (> 5%) adverse reactions associated with dupilumab treatment in clinical trials were:

Dupilumab promising for atopic dermatitis in phase 3 studies

Related information

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