Narrative review on the management of moderate-severe atopic dermatitis in pediatric age of the Italian Society of Pediatric Allergology and Immunology (SIAIP), of the Italian Society of Pediatric Dermatology (SIDerP) and of the Italian Society of Pediatrics (SIP)

Table 7 History of approvals of dupilumab for atopic dermatitis by international regulatory agencies

Approval date	FDA	EMA	AIFA
Adults with moderate to severe AD inadequately controlled	March 2017	September 2017	August 2018^a
Adolescents 12-17 years, with moderate to severe AD inadequately controlled	March 2019	August 2019	November 2020^b
Children 6-11 years, with moderate to severe AD inadequately controlled	May 2020	October 2020	January 2022^c

^aAdult patients with EASI score ≥ 24, for whom cyclosporine therapy is contraindicated, ineffective, or not tolerated. Reimbursement class: H, medicinal product subject to restrictive medical prescription, to be renewed from time to time, sold to the public on prescription from hospitals or dermatologist specialists (RNRL)
^bAdolescents eligible for systemic therapy without prior use of cyclosporine; medicine subject to a limited medical prescription, to be renewed from time to time, sold to the public on prescription from hospitals or specialists - dermatologist, pulmonologist, allergist, otolaryngologist, immunologist and pediatrician (RNRL)
^cFrom 20 December 2022 it is possible to use dupilumab in a reimbursable regime as an innovative non-oncological drug for the treatment of severe AD in children aged 6 to 11 eligible for systemic therapy who have an EASI score ≥24 or one of the following characteristics: localization in visible and / or sensitive areas; evaluation of pruritus with NRS ≥7 scale; quality of life assessment with CDLQI index ≥10

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