The European Commission has approved Sanofi and Regeneron’s biologic treatment Dupixent for the treatment of children aged six to 11 years with severe atopic dermatitis.
The approval is mainly based on data from pivotal phase III efficacy and safety results of Dupixent (dupilumab) combined with topical corticosteroids (TCS), compared to TCS alone in children aged six to 11 years with severe atopic dermatitis.
For children treated in the Dupixent arm, there was an 82% average improvement in disease extent and severity when the biologic was administered every four weeks, compared to 49% for placebo.
When Dupixent was administered every two weeks, participants demonstrated an 80% average improvement in disease extent and severity compared to 48% for placebo.
In addition, 33% and 39% of patients achieved clear or almost clear skin with Dupixent every four and two weeks respectively, compared to 11% and 10% for placebo.
The biologic treatment also led to a 51% and 61% reduction of itch when administered every four and two weeks, compared to 12% and 13% for placebo.
“This approval for Dupixent in the EU represents a major advancement for children with severe atopic dermatitis and their families, who spend countless days and nights tending to their child's disease with few treatment options to help alleviate the debilitating symptoms," said George Yancopoulos, president and chief scientific officer at Regeneron.
"Dupixent is a novel therapy that addresses a root cause of atopic dermatitis by specifically targeting the underlying type 2 inflammation of the disease. Dupixent has already been used by hundreds of thousands of patients around the world, including those with atopic dermatitis as well as other type 2 inflammatory diseases such as asthma and adults with chronic rhinosinusitis with nasal polyps,” he added.