(AOF) – The FDA has approved Sanofi’s Dupixent (dupilumab) for the treatment of children 6 months to 5 years of age with moderate to severe atopic dermatitis not controlled by topical prescription medications or to whom these medications are prescribed. not recommended. A regulatory submission for this same age group is currently under review by the European Medicines Agency and further regulatory submissions in various countries are ongoing.
Dupixent is the first and only biologic drug approved for the treatment of moderate to severe atopic dermatitis from infancy through adulthood.
In a Phase III trial in children, Dupixent in combination with topical corticosteroids showed better skin healing and significantly reduced itching at 16 weeks compared to treatment with topical corticosteroids. topical only.
Long-term safety data from a 52-week open-label extension trial in this age group support Dupixent’s well-established safety profile observed in all age groups for which it is approved.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: assessment of tolerance and efficacy on several hundred patients to identify side effects. Phase III: evaluation of the overall benefit/risk ratio with several thousand patients.
FDA (Food and Drug Administration)
Among the attributions of the Food and Drug Administration (the health authorities in the United States) there is in particular the issuance of marketing authorizations for all drugs intended for this country, which represents the world’s largest market for ‘pharmaceutical industry.
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