Fda approves dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

Children treated with dupixent and topical corticosteroids (tcs) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced itch compared to tcs alone at week 16 in a phase 3 trial long-term safety data from a 52-week open-label extension trial in this age group reinforce the well-established safety profile of dupixent observed across all other approved age groups dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood tarrytown, n.y. and paris , june 7, 2022 /prnewswire/ -- regeneron pharmaceuticals, inc. (nasdaq: regn) and sanofi today announced that the u.s. food and drug administration (fda) has approved dupixent® (dupilumab) 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 those therapies are not advisable.
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