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.
About Dupixent
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis.
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally.
March 23, 2023
