Tarrytown-headquartered Regeneron announced that the U.S. Food and Drug Administration (FDA) has approved its drug treatment Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis and cannot be treated with topical prescription therapies.
According to Regeneron, atopic dermatitis is a chronic type 2 inflammatory skin disease, with 85% to 90% of patients first developing symptoms before they reach 5 years of age. In the U.S., more than 75,000 children aged 5 years and younger have uncontrolled moderate-to-severe disease and are most in need of new treatment options.
The use of Dupixent ”“ which the company developed in collaboration with the French pharmaceutical company Sanofi ”“ in this age group is also under review by the European Medicines Agency, and submissions are underway with regulatory authorities in additional countries are underway.
“Young children with moderate-to-severe atopic dermatitis are a significantly underserved population of patients, who spend vulnerable years of their lives suffering through the relentless and far-reaching effects of this chronic disease,” said George D. Yancopoulos, president and chief scientific officer at Regeneron. “Dupixent has changed the atopic dermatitis treatment paradigm ”“ significantly clearing skin and reducing itch ”“ by targeting an underlying cause of this disease without broadly suppressing the immune system. Today”™s approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any U.S. patient aged six months or older living with this debilitating disease.”
