FDA Accepts Supplemental Biologic License Application for Dupilumab

Sanofi and Regeneron Pharmaceuticals announced that the Food and Drug Administration accepted a Supplemental Biologic License Application (sBLA) for dupilumab as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when therapies are not advisable/

The target action date for the FDA decision is June 9, 2022. If approved, dupilumab will be the first biologic medicine available in the US to treat uncontrolled moderate-to-severe atopic dermatitis for young children.

Recent studies have shown that the onset of atopic dermatitis takes place before the age of 5 years in 85-90% of patients, with symptoms continuing through adulthood.

New Phase 3 Data

Recent phase 3 results for dupilumab supported the sBLA, with the latest study evaluating the efficacy and safety of the biologic added to standard-of-care topical corticosteroids in children 6 month to 5 years old with uncontrolled moderate-to-severe atopic dermatitis.

The trial, which met all primary and secondary endpoints, showed that dupilumab and topical corticosteroids significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to topical corticosteroids alone.

A total of 28% of patients treated with dupilumab and topical corticosteroids achieved clear or almost-clear skin compared to 4% with placebo (p<0.0001), and a 70% average improvement from baseline in disease severity compared to a 20% improvement with placebo was also reported.

"One of most challenging aspects of my job as a physician is having limited treatment options to help babies and young children suffering from moderate-to-severe atopic dermatitis, which can disrupt their ability to fully thrive in these early years of life," said Amy S. Paller, MD, Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, and principal investigator of the trial.

"These results show dupilumab can significantly improve the signs and overall severity of atopic dermatitis in children as young as 6 months. Safety is of paramount importance when treating children at such a young age. We are encouraged that these data show a safety profile consistent with what has been seen in other age groups.”

Paller added that patients treated in this recent trial will continued to be followed for up to 5 years in an open-label trial.