EU Authorizes Dupixent for Young Kids With Severe Atopic Dermatitis

The European Commission has authorized Sanofi’s Dupixent (dupilumab) for use treating children six months years old to five years in the EU.

The approval was supported by 162-person phase 3 results which showed that patients given Dupixent plus low-potency topical corticosteroids had improved skin clearance and reduced overall disease severity and itching, when compared against those participants only given the steroids at 16 weeks of treatment.

In addition, Dupixent improved sleep quality, skin pain and health-related quality of life, while long-term efficacy data demonstrated that clinical benefit continued through 52 weeks.

Dupixent, a monoclonal antibody, works by blocking the signals of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways which are drivers of inflammation. An estimated 80,000 young children in Europe suffer from uncontrolled severe atopic dermatitis.